Z-1131-2021 Class II Terminated
FDA device recall Z-1131-2021 was initiated by Biomet, Inc. on January 15, 2021 and is designated Class II. Reason for recall: Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 4… The recall status is terminated (terminated March 9, 2023). Affected quantity: 49.
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2021
- Initiation Date
- January 15, 2021
- Termination Date
- March 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49
Product Description
Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Reason for Recall
Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Distribution Pattern
US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN.
Code Information
Model No.: 115395, Lot No.: 077170, UDI: (01) 00880304677074 (17) 301010 (10) 077170