CLASS II Device recall · Reported 19 Sep 2018 · FDA Enforcement Report

Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet

Zimmer Biomet is recalling Affixus¿ Hip Fracture Nail Left 125¿, distributed in 42 states. The recall was initiated on 17 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes245830 331620

Quantity recalled5947 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3101-2018
FDA event ID: 80755
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 17 Jul 2018
FDA classified: 13 Sep 2018
Reported: 19 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

17 Jul 2018	Recall initiated by company
13 Sep 2018	Classified by FDA	+58 days
19 Sep 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Product as listed by the FDA

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 320 mm, Item Number: 814413320

Where it was distributed

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

Alabama Arkansas Arizona California Colorado Florida Georgia Hawaii Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

The set screw is not able to advance or reverse from the original position in the nail.

Which lots are affected?

245830 331620

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 80755

This product is part of a recall event; the main page for the event is Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet.

Reported	Class	Recall	Company	Reason	Where
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states
19 Sep 2018	CLASS II	Affixus¿ Hip Fracture Nail Right 130¿ recalled by Zimmer Biomet	Zimmer Biomet	Other	42 states

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All 873

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30 Dec 2020Device	CLASS II	Spinal Rod Cutter recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
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11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide

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All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide