CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report
Attune Affixium Cementless Fixed Bearing Knee recalled
DePuy Orthopaedics is recalling Attune Affixium Cementless Fixed Bearing Knee with 3DP Technology, Size Component of the, distributed nationwide in the US. The recall was initiated on 12 Mar 2024 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-1456-2024
- FDA event ID
- 94222
- Recalling firm
- DePuy Orthopaedics, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Mar 2024
- FDA classified
- 29 Mar 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 12 Mar 2024 | Recall initiated by company | |
| 29 Mar 2024 | Classified by FDA | +17 days |
| 10 Apr 2024 | 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
Product incorrectly labelled.
Product as listed by the FDA
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Where it was distributed
Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
Questions about this recall
Why was it recalled?
Product incorrectly labelled.
Which lots are affected?
Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.
Where was it sold?
Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of 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.
More recalls from DePuy Orthopaedics
All 153| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 recalled | DePuy Orthopaedics | Other | Nationwide |
| Device | CLASS II | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled | DePuy Orthopaedics | Other | Nationwide |
| Device | CLASS II | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled | DePuy Orthopaedics | Other | Nationwide |
| Device | CLASS II | Attune Revision Limb Preservation System (LPS) Tibial Insert SM recalled | DePuy Orthopaedics | Other | Nationwide |
| Device | CLASS II | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM recalled | DePuy Orthopaedics | Other | Nationwide |
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| 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 |