Home / Recalls / DePuy Orthopaedics, Inc. / Z-2317-2017

Z-2317-2017 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
June 14, 2017
Initiation Date
January 6, 2017
Termination Date
May 15, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
345

Product Description

DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures

Reason for Recall

Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.

Distribution Pattern

Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA

Code Information

Unknown

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-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-1267-2023 Class II — Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 1516 (February 15, 2023)
  • 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-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-0631-2022 Class II — ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in (January 5, 2022)