FDA recall Z-0972-2019

Zimmer Biomet, Inc. · Class II · device

Product

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

US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.

Key facts

Status
Terminated
Initiation date
2018-12-21
Report date
2019-03-13
Termination date
2020-05-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0972-2019