CLASS II Device recall · Reported 1 Sep 2021 · FDA Enforcement Report
Attune Revision Cemented Stem 16X80MM-intended for use recalled
DePuy Orthopaedics is recalling Attune Revision Cemented Stem 16X80MM-intended for use in total knee arthroplasty. The recall was initiated on 1 Jul 2021 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-2348-2021
- FDA event ID
- 88413
- Recalling firm
- DePuy Orthopaedics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jul 2021
- FDA classified
- 25 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 1 Jul 2021 | Recall initiated by company | |
| 25 Aug 2021 | Classified by FDA | +55 days |
| 1 Sep 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
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
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Where it was distributed
International distribution in the countries of Canada, France.
Questions about this recall
Why was it recalled?
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Which lots are affected?
Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010
Where was it sold?
International distribution in the countries of Canada, France.
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 Affixium Cementless Fixed Bearing Knee recalled | DePuy Orthopaedics | Labeling Errors | Nationwide |
| 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 |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |