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 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
- Device Malfunction
- 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.
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
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.
Questions about this recall
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 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
4 other products · FDA event 96493This product is part of a recall event; the main page for the event is Biomet Ceramic Head Diameter, Type 1, +0 Neck recalled by Zimmer.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Biomet Ceramic Head Diameter, Type 1, +0 Neck recalled by Zimmer | Zimmer | Device Malfunction | Nationwide | |
| CLASS II | Biomet Ceramic Head Diameter, 12/14 Taper, +3 Neck recalled by Zimmer | Zimmer | Device Malfunction | Nationwide | |
| CLASS II | Biomet Ceramic Head Diameter, Type 1, +3 Neck recalled by Zimmer | Zimmer | Device Malfunction | Nationwide | |
| CLASS II | Biomet Ceramic Head Diameter, Type 1, -3 Neck recalled by Zimmer | Zimmer | Device Malfunction | Nationwide |
More recalls from Zimmer
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|---|---|---|---|---|---|
| Device | CLASS II | Off-Axis Comprehensive Shoulder System, Large, Augment recalled | Zimmer | Foreign Material | Nationwide |
| Device | CLASS II | Off-Axis Comprehensive Shoulder System Small, Augment recalled by Zimmer | Zimmer | Foreign Material | Nationwide |
| Device | CLASS II | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide recalled | Zimmer | Foreign Material | Nationwide |
| Device | CLASS II | Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled | Zimmer | Packaging Defects | IN |
| Device | CLASS II | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide recalled | Zimmer | Foreign Material | Nationwide |
Other Hip & Knee Implants recalls
All 3,110| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |