CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report
Biolox Ceramic Option Head Zimmer 12/14 +0 recalled by Biomet
Biomet is recalling Biolox Ceramic Option Head Zimmer 12/14 +0, distributed in 9 states. The recall was initiated on 2 Nov 2023 and the FDA has classified it as Class II.
Check your package
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-0570-2024
- FDA event ID
- 93486
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Nov 2023
- FDA classified
- 18 Dec 2023
- Reported
- 27 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 2 Nov 2023 | Recall initiated by company | |
| 18 Dec 2023 | Classified by FDA | +46 days |
| 27 Dec 2023 | 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
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
Where it was distributed
US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.
AlabamaCaliforniaMarylandMichiganNorth CarolinaOhioOklahomaTennesseeTexas
Questions about this recall
Why was it recalled?
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
Which lots are affected?
UDI-DI: 00889024430563; Lot Number: 3145300
Where was it sold?
US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. 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 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.
Other products in this recall event
1 other product · FDA event 93486| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Biolox Ceramic Option Head Zimmer 12/14 recalled by Biomet | Biomet | Packaging Defects | 9 states |
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|---|---|---|---|---|---|
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