The Recall Desk
ModerateFDA (Devices)·Z-0093-2021·Announced 2020-10-21

Biomet Shoulder Prosthesis Baseplate Packaging Error Recall

Biomet is recalling 3 units of Comprehensive Reverse Shoulder Glenosphere Mini Baseplates due to packaging errors where components may be missing or duplicated.

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. The hazard is a packaging error resulting in missing or incorrect components, which is a moderate risk but does not involve reported injuries or high-risk pathogens.

Plain-English summary

Biomet, Inc. is recalling three units of the Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter. This medical device is intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere). The recall is due to a packaging error where the product may be shipped without the required taper adapter or baseplate.

The source text indicates that the package should contain one baseplate and one taper adapter. However, affected units may be packaged with two baseplates and no adapters, or with no baseplates and two adapters. The affected lot numbers are 488150 and 564110. The products were distributed nationwide in the United States, including in the states of Colorado, Minnesota, Ohio, and Wyoming.

Healthcare providers and patients should check their inventory for these specific lot numbers. If the packaging does not match the required configuration of one baseplate and one taper adapter, the product should not be used. Biomet is the recalling firm responsible for this action.

The recalled product

Product
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).
Manufacturer
Biomet, Inc.
Affected units
3

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 (2)

  • Lot Numbers: 488150 -UDI (01) 00880304532465 (17) 300623 (10) 488150
  • and 564110- UDI (01) 00880304532465 (17) 300609 (10) 564110

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically: