Home / Recalls / DePuy Orthopaedics, Inc. / Z-1264-2023

Z-1264-2023 Class II Ongoing

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
March 29, 2023
Initiation Date
February 15, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7 units

Product Description

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

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 Pattern

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

Code Information

GTIN: 10603295490968; Lot: JP9016

Other recalls by DePuy Orthopaedics, Inc.

  • Z-1456-2024 Class II — ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Compo (March 12, 2024)
  • Z-1265-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Numb (February 15, 2023)
  • Z-1267-2023 Class II — Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 1516 (February 15, 2023)
  • Z-1266-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Numbe (February 15, 2023)
  • Z-1263-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Num (February 15, 2023)
  • Z-1419-2022 Class II — ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation o (June 29, 2022)
  • Z-1375-2022 Class II — MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic (May 18, 2022)
  • Z-1029-2022 Class II — VELYS Robotic-Assisted Solution Base Product No.: 451570100 (March 11, 2022)
  • Z-0632-2022 Class II — ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in tota (January 5, 2022)
  • Z-0631-2022 Class II — ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in (January 5, 2022)