Z-1615-2020 Class II Terminated
FDA device recall Z-1615-2020 was initiated by Biomet, Inc. on February 25, 2020 and is designated Class II. Reason for recall: Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters. The recall status is terminated (terminated August 5, 2020). Affected quantity: 21 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- February 25, 2020
- Termination Date
- August 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
Product Description
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589
Reason for Recall
Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
Distribution Pattern
International distribution - country of Netherland.s
Code Information
Lot Number: 410420 UDI: (01) 0 0880304 53246 5 (17) 290825 (10) 410420