FDA Enforcement
Class II
Terminated
Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
Recall: Z-0972-2019
·
Reported March 13, 2019
Enforcement
- Recall Number
- Z-0972-2019
- Event ID
- 81118
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 13, 2019
- Initiation Date
- December 21, 2018
- Classification Date
- March 1, 2019
- Termination Date
- May 6, 2020
- Address
- 56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States
Description
Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
Reason
The product was potentially being packaged without a taper adapter.
Code Info
Lot Numbers 994110, 921950 UDI Numbers: (01) 0 0880304 53246 5 (17) 280920 (10) 994110 (01) 0 0880304 53246 5 (17) 280913 (10) 921950
Distribution
US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.
Quantity
52