Device recall: Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601…

Class II FDA enforcement event 77417. Recall start date: 22 May 2017. Status in the FDA record: Terminated. Termination date: 29 Mar 2019.

Reason for recall, in the words of FDA

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Zimmer Biomet, Inc. started this device recall on 22 May 2017. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 77417 has 60 product records. The first FDA enforcement report date is 4 Oct 2017. The record gives the status Terminated, with the termination date 29 Mar 2019.

FDA enforcement report The 60 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan &…

Recalling firm

Zimmer Biomet, Inc., Warsaw, IN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

60 product records in the event.

FDA event 77417: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-3144-2017	Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile	2825 units	Class II	Terminated	4 Oct 2017
Z-3145-2017	Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile	18 units	Class II	Terminated	4 Oct 2017
Z-3146-2017	Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic surgical instrument.	2 units	Class II	Terminated	4 Oct 2017
Z-3147-2017	M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile. orthopedic surgical instrument.	25 units	Class II	Terminated	4 Oct 2017
Z-3148-2017	ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile. orthopedic surgical instrument.	751 units	Class II	Terminated	4 Oct 2017
Z-3149-2017	Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile. orthopedic surgical instrument.	171 units	Class II	Terminated	4 Oct 2017
Z-3150-2017	ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgical instrument.	4 units	Class II	Terminated	4 Oct 2017
Z-3151-2017	Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile. orthopedic surgical instrument.	1055 units	Class II	Terminated	4 Oct 2017
Z-3152-2017	Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument.	155 units	Class II	Terminated	4 Oct 2017
Z-3153-2017	Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile. orthopedic surgical instrument.	25 units	Class II	Terminated	4 Oct 2017
Z-3154-2017	NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm Length, Item Number/EDI 0200024325, Nonsterile. orthopedic surgical instrument.	300 units	Class II	Terminated	4 Oct 2017
Z-3155-2017	M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.	224 units	Class II	Terminated	4 Oct 2017
Z-3156-2017	ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile. orthopedic surgical instrument.	10 units	Class II	Terminated	4 Oct 2017
Z-3157-2017	NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orthopedic surgical instrument.	185 units	Class II	Terminated	4 Oct 2017
Z-3158-2017	M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile. orthopedic surgical instrument.	182 units	Class II	Terminated	4 Oct 2017
Z-3159-2017	M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI 00225503337, Nonsterile. orthopedic surgical instrument.	27 units	Class II	Terminated	4 Oct 2017
Z-3160-2017	M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile. orthopedic surgical instrument.	21 units	Class II	Terminated	4 Oct 2017
Z-3161-2017	ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile. orthopedic surgical instrument.	439 units	Class II	Terminated	4 Oct 2017
Z-3162-2017	ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, Nonsterile. orthopedic surgical instrument.	1999 units	Class II	Terminated	4 Oct 2017
Z-3163-2017	ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile. orthopedic surgical instrument.	1558 units	Class II	Terminated	4 Oct 2017
Z-3164-2017	ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile. orthopedic surgical instrument.	4,423 units	Class II	Terminated	4 Oct 2017
Z-3165-2017	ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile. orthopedic surgical instrument.	3,640 units	Class II	Terminated	4 Oct 2017
Z-3166-2017	ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile. orthopedic surgical instrument.	3,232 units	Class II	Terminated	4 Oct 2017
Z-3167-2017	ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. orthopedic surgical instrument.	2,240 units	Class II	Terminated	4 Oct 2017
Z-3168-2017	ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802700, Nonsterile. orthopedic surgical instrument.	1,250 units	Class II	Terminated	4 Oct 2017
Z-3169-2017	ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile. orthopedic surgical instrument.	1,286 units	Class II	Terminated	4 Oct 2017
Z-3170-2017	ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile. orthopedic surgical instrument.	1,255 units	Class II	Terminated	4 Oct 2017
Z-3171-2017	ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile. orthopedic surgical instrument.	2,038 units	Class II	Terminated	4 Oct 2017
Z-3172-2017	ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile. orthopedic surgical instrument.	356 units	Class II	Terminated	4 Oct 2017
Z-3173-2017	ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile. orthopedic surgical instrument.	389 units	Class II	Terminated	4 Oct 2017
Z-3174-2017	Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile. orthopedic surgical instrument.	173 units	Class II	Terminated	4 Oct 2017
Z-3175-2017	Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile. orthopedic surgical instrument.	62 units	Class II	Terminated	4 Oct 2017
Z-3176-2017	ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804500, Nonsterile. orthopedic surgical instrument.	381 units	Class II	Terminated	4 Oct 2017
Z-3177-2017	ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804506, Nonsterile. orthopedic surgical instrument.	217 units	Class II	Terminated	4 Oct 2017
Z-3178-2017	Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile. orthopedic surgical instrument.	198 units	Class II	Terminated	4 Oct 2017
Z-3179-2017	Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D., Item Number/EDI 00236017127, Nonsterile. orthopedic surgical instrument.	173 units	Class II	Terminated	4 Oct 2017
Z-3180-2017	Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile. orthopedic surgical instrument.	1,091 units	Class II	Terminated	4 Oct 2017
Z-3181-2017	Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, Item Number/EDI 00236020527, Nonsterile. orthopedic surgical instrument.	1,129 units	Class II	Terminated	4 Oct 2017
Z-3182-2017	ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length, Item Number/EDI 00241002000, Nonsterile. orthopedic surgical instrument.	418 units	Class II	Terminated	4 Oct 2017
Z-3183-2017	ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length, Item Number/EDI 00241002100, Nonsterile. orthopedic surgical instrument.	37 units	Class II	Terminated	4 Oct 2017
Z-3184-2017	ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Length, Item Number/EDI 00241002500, Nonsterile. orthopedic surgical instrument.	412 units	Class II	Terminated	4 Oct 2017
Z-3185-2017	ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item Number/EDI 00241002600, Nonsterile. orthopedic surgical instrument.	198 units	Class II	Terminated	4 Oct 2017
Z-3186-2017	ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile. orthopedic surgical instrument.	240 units	Class II	Terminated	4 Oct 2017
Z-3187-2017	ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item Number/EDI 00241003500, Nonsterile. orthopedic surgical instrument.	62 units	Class II	Terminated	4 Oct 2017
Z-3188-2017	ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item Number/EDI 00241004000, Nonsterile. orthopedic surgical instrument.	10 units	Class II	Terminated	4 Oct 2017
Z-3189-2017	Zimmer Natural Nail System Calibrated Drill Short 4.9 mm, Item Number/EDI 00249006449, Nonsterile. orthopedic surgical instrument.	62 units	Class II	Terminated	4 Oct 2017
Z-3190-2017	Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520, Nonsterile. orthopedic surgical instrument.	30 units	Class II	Terminated	4 Oct 2017
Z-3191-2017	Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 00480513032, Nonsterile. orthopedic surgical instrument.	228 units	Class II	Terminated	4 Oct 2017
Z-3192-2017	Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 00480608515, Nonsterile. orthopedic surgical instrument.	705 units	Class II	Terminated	4 Oct 2017
Z-3193-2017	Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile. orthopedic surgical instrument.	2,585 units	Class II	Terminated	4 Oct 2017
Z-3194-2017	Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length, Item Number/EDI 00480610027, Nonsterile. orthopedic surgical instrument.	701 units	Class II	Terminated	4 Oct 2017
Z-3195-2017	Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025, Nonsterile. orthopedic surgical instrument.	1,550 units	Class II	Terminated	4 Oct 2017
Z-3196-2017	Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035, Nonsterile. orthopedic surgical instrument.	3,154 units	Class II	Terminated	4 Oct 2017
Z-3197-2017	Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, Nonsterile. orthopedic surgical instrument.	236 units	Class II	Terminated	4 Oct 2017
Z-3198-2017	Drill bit Quick-Connect 3-Fluted 2.5 mm Diameter 180 mm Length, Item Number/EDI 00480718025, Nonsterile. orthopedic surgical instrument.	595 units	Class II	Terminated	4 Oct 2017
Z-3199-2017	Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic surgical instrument.	15 units	Class II	Terminated	4 Oct 2017
Z-3200-2017	Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item Number/EDI 00480723025, Nonsterile. orthopedic surgical instrument.	453 units	Class II	Terminated	4 Oct 2017
Z-3201-2017	Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item Number/EDI 00249007543, Nonsterile. orthopedic surgical instrument.	2,037 units	Class II	Terminated	4 Oct 2017
Z-3202-2017	Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile. orthopedic surgical instrument.	150 units	Class II	Terminated	4 Oct 2017
Z-3203-2017	Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic surgical instrument.	75 units	Class II	Terminated	4 Oct 2017

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2017: 1,091
Share of these events in Class II: 93%
Product records in this event: 60Median of the firm: 1
Events of the firm on the register: 144

Other events of the firm

Other FDA enforcement events of Zimmer Biomet, Inc.
Initiated	Product (first record)	Type	Class	Records
20 Nov 2020	Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of	Device	Class II	1
17 Nov 2020	Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system	Device	Class II	1
24 Sep 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item Nu	Device	Class II	75
14 Aug 2020	Dual Mobility Vivacit-E Bearing, Model Number 110031009	Device	Class II	1
5 May 2020	Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cerv	Device	Class II	25
7 Jan 2020	THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451	Device	Class II	1
23 Dec 2019	Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00	Device	Class II	1
19 Dec 2019	ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orth	Device	Class II	1
12 Dec 2019	Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)0088902427400	Device	Class II	1
25 Oct 2019	Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660	Device	Class II	2

Zimmer Biomet, Inc.: all 144 events

Official channels

FDA enforcement report Z-3144-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 77417. https://recallregister.com/fda/ii/77417/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan &…
What quantity of product is in FDA event 77417?: The event has 60 product records. The first record gives this quantity: 2825 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2017 have the same class?: 93% of the 1,091 device events that started in 2017 are in Class II.