Food, drugs, devices › DePuy Orthopaedics, Inc.
Device recall: Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
FDA enforcement event 91752 is a device recall by DePuy Orthopaedics, Inc. of Warsaw, IN, initiated 15 Feb 2023 and classified Class II, with 5 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. DePuy Orthopaedics, Inc. has 59 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
DePuy Orthopaedics, Inc., Warsaw, IN.
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."
Distribution
"Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1263-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118 | 7 units | Class II | Ongoing | 29 Mar 2023 |
| Z-1264-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212 | 7 units | Class II | Ongoing | 29 Mar 2023 |
| Z-1265-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226 | 7 units | Class II | Ongoing | 29 Mar 2023 |
| Z-1266-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312 | 7 units | Class II | Ongoing | 29 Mar 2023 |
| Z-1267-2023 | Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507 | 12 units | Class II | Ongoing | 29 Mar 2023 |
Context
Other enforcement events for DePuy Orthopaedics, Inc.
All 59 events for DePuy Orthopaedics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.