CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report

fastener, fixation, nondegradable, soft tissue recalled by Zimmer Biomet

Zimmer Biomet is recalling fastener, fixation, nondegradable, soft tissue, distributed in 11 states. The recall was initiated on 25 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370

Quantity recalled429 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-1009-2018
FDA event ID: 79273
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 25 Oct 2017
FDA classified: 14 Mar 2018
Reported: 21 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

25 Oct 2017	Recall initiated by company
14 Mar 2018	Classified by FDA	+140 days
21 Mar 2018	Published in enforcement report	+7 days

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

Reason for recall

It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

fastener, fixation, nondegradable, soft tissue

Where it was distributed

TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT

Alabama Connecticut Florida Indiana North Carolina New Jersey New York Pennsylvania Texas Virginia Wisconsin

Questions about this recall

Why was it recalled?

It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.

Which lots are affected?

Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370

Where was it sold?

TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT

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.

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