FDA-Device2020-10-21Class II
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).
Biomet, Inc.
Hazard
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
Sold states
US Nationwide distribution including in the states of CO, MN, OH, WY.
Affected count
3 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0093-2021Don't want to check this manually?
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