Home / Recalls / DePuy Orthopaedics, Inc. / Z-1419-2022

Z-1419-2022 Class II Ongoing

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
July 27, 2022
Initiation Date
June 29, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
872 units

Product Description

ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525

Reason for Recall

Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

Distribution Pattern

Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam

Code Information

GTIN: 10603295434061 Lots: AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303

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-1267-2023 Class II — Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 1516 (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-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)
  • Z-0632-2022 Class II — ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in tota (January 5, 2022)