Z-0972-2019 Class II Terminated
FDA device recall Z-0972-2019 was initiated by Zimmer Biomet, Inc. on Dec 21, 2018 and is designated Class II. Reason for recall: The product was potentially being packaged without a taper adapter. The recall status is terminated (terminated May 6, 2020). Affected quantity: 52.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 13, 2019
- Initiation Date
- Dec 21, 2018
- Termination Date
- May 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52
Product 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 for Recall
The product was potentially being packaged without a taper adapter.
Distribution Pattern
US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.
Code Information
Lot Numbers 994110, 921950 UDI Numbers: (01) 0 0880304 53246 5 (17) 280920 (10) 994110 (01) 0 0880304 53246 5 (17) 280913 (10) 921950
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0972-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026