Home / Recalls / DePuy Orthopaedics, Inc. / Z-0485-2022

Z-0485-2022 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
January 19, 2022
Initiation Date
December 7, 2021
Termination Date
May 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600

Reason for Recall

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

Code Information

Lot #: 9887449 GTIN:10603295004059

Other recalls by DePuy Orthopaedics, Inc.

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  • 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-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)