CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report

Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet

Zimmer Biomet is recalling Affixus Hip Fracture Nail, RH 125 DEG, distributed nationwide in the US. The recall was initiated on 7 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem No. 814313260; Lot No. (Exp. Date) UDI: 760270 (06/12/2027) UDI (01)00887868038211 (17)270612 (10)760270

Quantity recalled638 units

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-0452-2018
FDA event ID: 78763
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 7 Aug 2017
FDA classified: 29 Jan 2018
Reported: 7 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

7 Aug 2017	Recall initiated by company
29 Jan 2018	Classified by FDA	+175 days
7 Feb 2018	Published in enforcement report	+9 days

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

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Product as listed by the FDA

Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM

Where it was distributed

US nationwide distribution. Also Portugal and the Netherlands.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Item No. 814313260; Lot No. (Exp. Date) UDI: 760270 (06/12/2027) UDI (01)00887868038211 (17)270612 (10)760270

Where was it sold?

US nationwide distribution. Also Portugal and the Netherlands.

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

64 other products · FDA event 78763

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

Reported	Class	Recall	Company	Reason	Where
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 125 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, RH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
7 Feb 2018	CLASS II	Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide

More recalls from Zimmer Biomet

All 873

Reported	Class	Recall	Company	Reason	Where
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. recalled	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

Other Hip & Knee Implants recalls

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