Recall Z-1131-2021
Biomet, Inc. · initiated January 15, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Codes / lots: Model No.: 115395, Lot No.: 077170, UDI: (01) 00880304677074 (17) 301010 (10) 077170
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.
FDA-determined cause: Labeling Change Control
Action taken
On 01/19/2019, Zimmer Biomet issued Urgent Medical Device Recall notices to distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory will be notified via FedEx. 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.
Details
- Recall number
- Z-1131-2021
- Initiated
- January 15, 2021
- Terminated
- March 9, 2023
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Quantity
- 49
- Distribution
- US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN.
- Recalling firm
- Biomet, Inc., Warsaw, IN