Device recall: Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Class II FDA enforcement event 76629. Recall start date: 28 Feb 2017. Status in the FDA record: Terminated. Termination date: 27 Feb 2018.

Reason for recall, in the words of FDA

Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

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 28 Feb 2017. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 76629 has 35 product records. The first FDA enforcement report date is 21 Jun 2017. The record gives the status Terminated, with the termination date 27 Feb 2018.

FDA enforcement report The 35 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.

Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan,…

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

35 product records in the event.

FDA event 76629: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2549-2017	Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2550-2017	Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2551-2017	Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2552-2017	Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2553-2017	Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2554-2017	Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2555-2017	Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	N/A	Class II	Terminated	21 Jun 2017
Z-2556-2017	Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2557-2017	Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	N/A	Class II	Terminated	21 Jun 2017
Z-2558-2017	Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2559-2017	Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2560-2017	Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2561-2017	Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2562-2017	Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2563-2017	Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2564-2017	Fem IM Nail 14mmdx50cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2565-2017	Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2566-2017	Segmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2567-2017	Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2568-2017	Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2569-2017	Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2570-2017	Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2571-2017	Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2572-2017	Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2573-2017	Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2574-2017	Segmental fluted stem, 18x250mm bwd, Sterile,	9867	Class II	Terminated	21 Jun 2017
Z-2575-2017	Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2576-2017	Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2577-2017	Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2578-2017	Por fullct fem st 16x200mm, Sterile,	9867	Class II	Terminated	21 Jun 2017
Z-2579-2017	Por fullct fem st 17x200mm, Sterile,	9867	Class II	Terminated	21 Jun 2017
Z-2580-2017	Por fullct fem st 18x200mm, Sterile,	9867	Class II	Terminated	21 Jun 2017
Z-2581-2017	Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2582-2017	Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 2017
Z-2583-2017	Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	9867	Class II	Terminated	21 Jun 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: 35Median 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-2549-2017The 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 76629. https://recallregister.com/fda/ii/76629/. 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: Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan,…
What quantity of product is in FDA event 76629?: The event has 35 product records. The first record gives this quantity: 9867
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.