Z-0093-2021 Class II Terminated
FDA device recall Z-0093-2021 was initiated by Biomet, Inc. on Sep 2, 2020 and is designated Class II. Reason for recall: Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no… The recall status is terminated (terminated Dec 31, 2020). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 21, 2020
- Initiation Date
- Sep 2, 2020
- Termination Date
- Dec 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).
Reason for Recall
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
Distribution Pattern
US Nationwide distribution including in the states of CO, MN, OH, WY.
Code Information
Lot Numbers: 488150 -UDI (01) 00880304532465 (17) 300623 (10) 488150; and 564110- UDI (01) 00880304532465 (17) 300609 (10) 564110
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0093-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026