CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report
Depuy Synthes, Attune Revision Hinge Femoral LT SZ 7 Cem recalled
Depuy (Ireland) is recalling Depuy Synthes, Attune Revision Hinge Femoral LT SZ 7 Cem, distributed nationwide in the US. The recall was initiated on 3 Apr 2026 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-1987-2026
- FDA event ID
- 98707
- Recalling firm
- Depuy (Ireland), Co. Cork
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Apr 2026
- FDA classified
- 29 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 3 Apr 2026 | Recall initiated by company | |
| 29 Apr 2026 | Classified by FDA | +26 days |
| 6 May 2026 | 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
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Where it was distributed
US Nationwide distribution in the states of MN, NC, TX.
Questions about this recall
Why was it recalled?
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Which lots are affected?
Part Number: 150450107. UDI-DI: 10603295533139. Lot Number: 1006440. Expiration Date: 11/30/2035.
Where was it sold?
US Nationwide distribution in the states of MN, NC, TX.
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
8 other products · FDA event 98707This product is part of a recall event; the main page for the event is Depuy Synthes, Attune Revision Hinge Femoral LT SZ 8 Cem recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Depuy Synthes, Attune Revision Hinge Femoral LT SZ 8 Cem recalled | Depuy (Ireland) | Sterility | Nationwide | |
| CLASS II | Depuy Synthes, Attune Revision Hinge Femoral LT SZ 5 Cem recalled | Depuy (Ireland) | Sterility | Nationwide | |
| CLASS II | Depuy Synthes, Attune Revision Hinge Femoral RT SZ 5 Cem recalled | Depuy (Ireland) | Sterility | Nationwide | |
| CLASS II | Depuy Synthes, Attune Revision Hinge Femoral RT SZ 8 Cem recalled | Depuy (Ireland) | Sterility | Nationwide | |
| CLASS II | Depuy Synthes, Attune Revision Hinge Femoral RT SZ 3 Cem recalled | Depuy (Ireland) | Sterility | Nationwide | |
| CLASS II | Depuy Synthes, Attune Revision Hinge Femoral RT SZ 7 Cem recalled | Depuy (Ireland) | Sterility | Nationwide | |
| CLASS II | Depuy Synthes, Attune Revision Hinge Femoral LT SZ 4 Cem recalled | Depuy (Ireland) | Sterility | Nationwide | |
| CLASS II | Depuy Synthes, Attune Revision Hinge Femoral RT SZ 4 Cem recalled | Depuy (Ireland) | Sterility | Nationwide |
More recalls from Depuy (Ireland)
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Depuy Synthes, Attune Revision Hinge Knee Hinge Housing recalled | Depuy (Ireland) | Sterility | MN, NC, TX |
| Device | CLASS II | Depuy Synthes, Attune Revision Hinge Knee Hinge Insert recalled | Depuy (Ireland) | Sterility | MN, NC, TX |
| Device | CLASS II | Depuy Synthes, Attune Revision Hinge Femoral RT SZ 4 Cem recalled | Depuy (Ireland) | Sterility | Nationwide |
| Device | CLASS II | Depuy Synthes, Attune Revision Hinge Femoral LT SZ 4 Cem recalled | Depuy (Ireland) | Sterility | Nationwide |
| Device | CLASS II | Depuy Synthes, Attune Revision Hinge Femoral RT SZ 7 Cem recalled | Depuy (Ireland) | Sterility | 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 |