Device recall: Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures

Class II FDA enforcement event 81038. Recall start date: 8 Aug 2018. Status in the FDA record: Terminated. Termination date: 30 Jul 2020.

Reason for recall, in the words of FDA

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

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 8 Aug 2018. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 81038 has 48 product records. The first FDA enforcement report date is 24 Oct 2018. The record gives the status Terminated, with the termination date 30 Jul 2020.

FDA enforcement report The 48 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 in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN,…

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

48 product records in the event.

FDA event 81038: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0122-2019	Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures	153	Class II	Terminated	24 Oct 2018
Z-0123-2019	Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures	24	Class II	Terminated	24 Oct 2018
Z-0124-2019	Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Product Usage: Intended for the fixation of fractures	72	Class II	Terminated	24 Oct 2018
Z-0125-2019	Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures	38	Class II	Terminated	24 Oct 2018
Z-0126-2019	Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 Product Usage: Intended for the fixation of fractures	51	Class II	Terminated	24 Oct 2018
Z-0127-2019	Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures	24	Class II	Terminated	24 Oct 2018
Z-0128-2019	Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures	19	Class II	Terminated	24 Oct 2018
Z-0129-2019	Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fractures	14	Class II	Terminated	24 Oct 2018
Z-0130-2019	Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures	20	Class II	Terminated	24 Oct 2018
Z-0131-2019	Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures	153	Class II	Terminated	24 Oct 2018
Z-0132-2019	Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures	27	Class II	Terminated	24 Oct 2018
Z-0133-2019	Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures	12	Class II	Terminated	24 Oct 2018
Z-0134-2019	Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures	20	Class II	Terminated	24 Oct 2018
Z-0135-2019	Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 Product Usage: Intended for the fixation of fractures	51	Class II	Terminated	24 Oct 2018
Z-0136-2019	Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures	20	Class II	Terminated	24 Oct 2018
Z-0137-2019	Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures	18	Class II	Terminated	24 Oct 2018
Z-0138-2019	Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures	34	Class II	Terminated	24 Oct 2018
Z-0139-2019	Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures	24	Class II	Terminated	24 Oct 2018
Z-0140-2019	Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Product Usage: Intended for the fixation of fractures	22	Class II	Terminated	24 Oct 2018
Z-0141-2019	Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 Product Usage: Intended for the fixation of fractures	27	Class II	Terminated	24 Oct 2018
Z-0142-2019	Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 Product Usage: Intended for the fixation of fractures	9	Class II	Terminated	24 Oct 2018
Z-0143-2019	Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures	10	Class II	Terminated	24 Oct 2018
Z-0144-2019	Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures	25	Class II	Terminated	24 Oct 2018
Z-0145-2019	Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Product Usage: Intended for the fixation of fractures	16	Class II	Terminated	24 Oct 2018
Z-0146-2019	Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures	78	Class II	Terminated	24 Oct 2018
Z-0147-2019	Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures	14	Class II	Terminated	24 Oct 2018
Z-0148-2019	Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures	29	Class II	Terminated	24 Oct 2018
Z-0149-2019	Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures	30	Class II	Terminated	24 Oct 2018
Z-0150-2019	Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures	33	Class II	Terminated	24 Oct 2018
Z-0151-2019	Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures	15	Class II	Terminated	24 Oct 2018
Z-0152-2019	Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures	60	Class II	Terminated	24 Oct 2018
Z-0153-2019	Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures	68	Class II	Terminated	24 Oct 2018
Z-0154-2019	Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures	16	Class II	Terminated	24 Oct 2018
Z-0155-2019	Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures	31	Class II	Terminated	24 Oct 2018
Z-0156-2019	Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures	32	Class II	Terminated	24 Oct 2018
Z-0157-2019	Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures	22	Class II	Terminated	24 Oct 2018
Z-0158-2019	Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures	85	Class II	Terminated	24 Oct 2018
Z-0159-2019	Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures	39	Class II	Terminated	24 Oct 2018
Z-0160-2019	Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures	24	Class II	Terminated	24 Oct 2018
Z-0161-2019	Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures	44	Class II	Terminated	24 Oct 2018
Z-0162-2019	Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures	20	Class II	Terminated	24 Oct 2018
Z-0163-2019	Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures	50	Class II	Terminated	24 Oct 2018
Z-0164-2019	Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures	19	Class II	Terminated	24 Oct 2018
Z-0165-2019	Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures	14	Class II	Terminated	24 Oct 2018
Z-0166-2019	Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures	41	Class II	Terminated	24 Oct 2018
Z-0167-2019	Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures	16	Class II	Terminated	24 Oct 2018
Z-0168-2019	Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures	10	Class II	Terminated	24 Oct 2018
Z-0169-2019	Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures	20	Class II	Terminated	24 Oct 2018

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 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 48Median 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-0122-2019The 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 81038. https://recallregister.com/fda/ii/81038/. 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 in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN,…
What quantity of product is in FDA event 81038?: The event has 48 product records. The first record gives this quantity: 153
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.