CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report
Biomet Ceramic Head Diameter, 12/14 Taper, +0 Neck recalled by Zimmer
Zimmer is recalling Zimmer Biomet Ceramic Head Diameter, 12/14 Taper, +0 Neck, distributed nationwide in the US. The recall was initiated on 24 Mar 2025 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-1645-2025
- FDA event ID
- 96493
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Mar 2025
- FDA classified
- 21 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 24 Mar 2025 | Recall initiated by company | |
| 21 Apr 2025 | Classified by FDA | +28 days |
| 30 Apr 2025 | 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
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.
Stores named: Walmart
Questions about this recall
Is Biomet Ceramic Head Diameter, 12/14 Taper, +0 Neck recalled?
Yes. Zimmer recalled Biomet Ceramic Head Diameter, 12/14 Taper, +0 Neck on 24 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1645-2025.
Why was it recalled?
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Which lots are affected?
GTIN 00887868376320, All lots distributed with IFU 87-6204-051-99 Rev D or prior
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.
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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