Home / Recalls / DePuy Orthopaedics, Inc. / Z-2348-2021

Z-2348-2021 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
September 1, 2021
Initiation Date
July 1, 2021
Termination Date
February 1, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7 units

Product Description

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

Reason for Recall

Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

Distribution Pattern

International distribution in the countries of Canada, France.

Code Information

Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010

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-1264-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Numb (February 15, 2023)
  • 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-1263-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Num (February 15, 2023)
  • Z-1266-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Numbe (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)