DePuy recalls Attune Revision Limb Preservation System Tibial Insert XXSM 18MM with higher radiation dose that may alter implant material. Affected units have specific part number and lot code.
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.
Take action
Contact the company
📍Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr · Warsaw, IN 46582-3994
“DePuy Attune Revision Limb Preservation System Tibial Insert Recall: Radiation Dose Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/58881-depuy-attune-revision-limb-preservation-system-tibial-insert-recall-radiation. Based on FDA recall #Z-1263-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1263-2023%22&limit=1).
The FDA announced on Feb. 15, 2023, that DePuy Orthopaedics is recalling the Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM due to excessive irradiation doses that may alter implant material properties. The agency issued recall number Z-1263-2023 for the Class II device.
How to tell if you have it
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM
Part Number 151760118
UPC 10603295491095
Lot JP6452
The hazard
According to the FDA, the recalled lots received a higher than specified irradiation dose, exceeding the validated range for gamma radiation exposure. This excess exposure may result in changes to the implant material properties.
Context
GovInfoNow's records show DePuy Orthopaedics has issued 23 other recalls since July 12, 2017. Recent issues include a March 12, 2024 recall of ATTUNE Knee Components for incorrect labeling and a June 29, 2022 recall of the ATTUNE Sizing Guide due to corroded springs. Other recent recalls of similar products include Depuy ATTUNE Revision Hinge Femoral LT SZ 5 CEM (April 3, 2026) and Depuy ATTUNE Revision Hinge Knee Insert Components (May 19, 2026).
How to tell if you have this one
Check for part number 151760118 and lot code JP6452 on the implant. The product was sold with GTIN 10603295491095 during the production period.
Brand
DePuy
Product
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Category
Medical device
FDA recall event · 5 products
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
Recall number
Product, codes & lots
Quantity
Z-1263-2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118; GTIN: 10603295491095; Lot: JP6452
7 units
Z-1264-2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212; GTIN: 10603295490968; Lot: JP9016
7 units
Z-1265-2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226; GTIN: 10603295491033; Lot: JP9022
7 units
Z-1266-2023
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312; GTIN: 10603295490869; Lot: JP6464
7 units
Z-1267-2023
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507; GTIN: 10603295049944; Lot: JN6613
12 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for part number 151760118 and lot code JP6452 on the implant.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1263-2023 (February 15, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1263-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.