PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 8, 2020 Initiated: February 25, 2020 #Z-1615-2020

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.

Details

Recalling Firm
Biomet, Inc.
Units Affected
21 units
Distribution
International distribution - country of Netherland.s
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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. Recalled by Biomet, Inc.. Units affected: 21 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 8, 2020. Severity: Moderate. Recall number: Z-1615-2020.