CLASS II ONGOING Device recall · Reported 29 Mar 2023 · FDA Enforcement Report
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled
DePuy Orthopaedics is recalling Attune Revision Limb Preservation System (LPS) Tibial Insert XSM, distributed nationwide in the US. The recall was initiated on 15 Feb 2023 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-1265-2023
- FDA event ID
- 91752
- Recalling firm
- DePuy Orthopaedics, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Feb 2023
- FDA classified
- 17 Mar 2023
- Reported
- 29 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 15 Feb 2023 | Recall initiated by company | |
| 17 Mar 2023 | Classified by FDA | +30 days |
| 29 Mar 2023 | 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
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Product as listed by the FDA
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
Questions about this recall
Is Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled?
Yes. DePuy Orthopaedics recalled Attune Revision Limb Preservation System (LPS) Tibial Insert XSM on 15 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1265-2023.
Why was it recalled?
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Which lots are affected?
GTIN: 10603295491033; Lot: JP9022
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
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.
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 SM recalled | DePuy Orthopaedics | Other | Nationwide |
| Device | CLASS II | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 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 | Nitrosamine Impurity | 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) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |