FDA Device recall Z-1264-2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
- FDA Device
- Class II
- ongoing
- Published 2023-03-29
On 2023-03-29 the FDA classified a Class II recall of Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212 by Depuy Orthopaedics, citing 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 the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1264-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-15 |
| Published | 2023-03-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
Reason
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.
Identifiers
| code_info | GTIN: 10603295490968; Lot: JP9016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Depuy Orthopaedics
- ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System
FDA Device · Class II · 2024-04-10 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics
All Depuy Orthopaedics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1264-2023%22
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