Home / Recalls / DePuy Orthopaedics, Inc. / Z-1315-2021

Z-1315-2021 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

FDA device recall Z-1315-2021 was initiated by DePuy Orthopaedics, Inc. on February 22, 2021 and is designated Class II. Reason for recall: Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affe… The recall status is terminated (terminated October 11, 2023). Affected quantity: 102 units total (Domestic: 0 units, Foreign: 162 units).

Recall Details

Product Type: Devices
Report Date: April 7, 2021
Initiation Date: February 22, 2021
Termination Date: October 11, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 102 units total (Domestic: 0 units, Foreign: 162 units)

Product Description

The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

Reason for Recall

Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, France, Germany, Great Britain, Ireland, Israel, Italy, Macedonia, Mauritius, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Arab Emirates, China, Hong Kong, Japan, New Zealand, Korea, Singapore, Thailand.

Code Information

Lot#: 9543538, Product Code: 129433130, GTIN 10603295025788 Lot#: 9553989, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554547, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554548, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554551, Product Code: 129433130, GTIN 10603295025788 Lot#: 9548774, Product Code: 129433140, GTIN 10603295025795 Lot#: 9548777, Product Code: 129433140, GTIN 10603295025795 Lot#: 9554569, Product Code: 129433140, GTIN 10603295025795

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-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-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)