CLASS II Device recall · Reported 10 Jan 2018 · FDA Enforcement Report

Oss Cemented Im Stem recalled by Zimmer Biomet

Zimmer Biomet is recalling Oss Cemented Im Stem, distributed nationwide in the US. The recall was initiated on 5 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 71180

Quantity recalledN/A

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-0303-2018
FDA event ID: 78167
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 5 Jun 2017
FDA classified: 29 Dec 2017
Reported: 10 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

5 Jun 2017	Recall initiated by company
29 Dec 2017	Classified by FDA	+207 days
10 Jan 2018	Published in enforcement report	+12 days

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

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Product as listed by the FDA

OSS CEMENTED IM STEM 12X150, model # 150366

Where it was distributed

Nationwide in US; Internationally Argentina, Netherlands & Canada

Nationwide

Questions about this recall

Why was it recalled?

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Which lots are affected?

Lot Number: 71180

Where was it sold?

Nationwide in US; Internationally Argentina, Netherlands & Canada

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

9 other products · FDA event 78167

This product is part of a recall event; the main page for the event is Red Sexp Dstl Fem Rt Assy recalled by Zimmer Biomet.

Reported	Class	Recall	Company	Reason	Where
10 Jan 2018	CLASS II	Red Sexp Dstl Fem Rt Assy recalled by Zimmer Biomet	Zimmer Biomet	Labeling Errors	Nationwide
10 Jan 2018	CLASS II	Cer Option Type 1 Tpr Sleve recalled by Zimmer Biomet	Zimmer Biomet	Labeling Errors	Nationwide
10 Jan 2018	CLASS II	Lateral Troch Plate Full Crimp recalled by Zimmer Biomet	Zimmer Biomet	Labeling Errors	Nationwide
10 Jan 2018	CLASS II	Comp Hum Frac Stem Macro recalled by Zimmer Biomet	Zimmer Biomet	Labeling Errors	Nationwide
10 Jan 2018	CLASS II	Red Sexp Dstl Fem Lt Assy recalled by Zimmer Biomet	Zimmer Biomet	Labeling Errors	Nationwide
10 Jan 2018	CLASS II	Comp Primary Stem Mini recalled by Zimmer Biomet	Zimmer Biomet	Labeling Errors	Nationwide
10 Jan 2018	CLASS II	Cer Bioloxd Option Hd recalled by Zimmer Biomet	Zimmer Biomet	Labeling Errors	Nationwide
10 Jan 2018	CLASS II	Lateral Troch Plate Full Crimp recalled by Zimmer Biomet	Zimmer Biomet	Labeling Errors	Nationwide
10 Jan 2018	CLASS II	Echo Por Fmrl Nc recalled by Zimmer Biomet	Zimmer Biomet	Labeling Errors	Nationwide

More recalls from Zimmer Biomet

All 873

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30 Dec 2020Device	CLASS II	Spinal Rod Cutter recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
23 Dec 2020Device	CLASS II	Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal recalled	Zimmer Biomet	Device Malfunction	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.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
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 13,778

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