DePuy Orthopaedics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1264-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212

Product Classification:

Class II

Date Initiated: February 15, 2023

Date Posted: March 29, 2023

Recall Number: Z-1264-2023

Event ID: 91752

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.

Status: Ongoing

Product Quantity: 7 units

Code Information:

GTIN: 10603295490968; Lot: JP9016

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand

Voluntary or Mandated:

Voluntary: Firm initiated