The Recall Desk
ModerateFDA (Devices)·Z-0972-2019·Announced 2019-03-13

Zimmer Biomet Recalls Reverse Shoulder Baseplates Due to Missing Adapter

Zimmer Biomet is recalling 52 Comprehensive Reverse Shoulder System Glenosphere Mini Baseplates that may be missing a taper adapter.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a missing component (taper adapter) which is a functional defect rather than a direct biological or physical injury risk like infection or fracture.

Plain-English summary

Zimmer Biomet, Inc. is recalling 52 units of the Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589. The recall was initiated because the products were potentially packaged without the required taper adapter.

The affected units are identified by Lot Numbers 994110 and 921950. These products were distributed in the United States to Arkansas, Kentucky, and Washington, as well as internationally to Australia and Japan. The devices are indicated for use in patients with a grossly deficient rotator cuff and severe arthropathy.

Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these specific units.

The recalled product

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/o
Affected units
52

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers 994110

Distribution

Distributed in 3 states: