Z-1103-2021 Class II Terminated
FDA device recall Z-1103-2021 was initiated by DePuy Orthopaedics, Inc. on January 8, 2021 and is designated Class II. Reason for recall: The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots. The recall status is terminated (terminated January 17, 2024). Affected quantity: 60 sleeves.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2021
- Initiation Date
- January 8, 2021
- Termination Date
- January 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 sleeves
Product Description
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Reason for Recall
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.
Code Information
Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92