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

Cer Bioloxd Option Hd recalled by Zimmer Biomet

Zimmer Biomet is recalling Cer Bioloxd Option Hd, 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: 843260

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-0302-2018
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

CER BIOLOXD OPTION HD 32MM, model # 650-1056

Where it was distributed

Nationwide in US; Internationally Argentina, Netherlands & Canada

Nationwide

Questions about this recall

Is Cer Bioloxd Option Hd recalled?

Yes. Zimmer Biomet recalled Cer Bioloxd Option Hd on 5 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0302-2018.

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: 843260

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 21 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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