The Recall Desk
ModerateFDA (Devices)·Z-1615-2020·Announced 2020-04-08

Biomet Shoulder Baseplate Recall Due to Incorrect Packaging Contents

Biomet is recalling 21 units of Comprehensive Reverse Shoulder Glenosphere Mini Baseplates because some packages contained two baseplates and no taper adapters.

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: This is a Class II recall involving a packaging error that results in missing components, which is a moderate risk of improper use but does not involve a direct safety hazard like contamination or structural failure.

Plain-English summary

Biomet, Inc. is recalling 21 units of the Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter (Item Number: 010000589). The recall is due to a packaging error where some devices were packaged with two baseplates and no taper adapters, instead of the intended one baseplate and one taper adapter.

The affected products are indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The specific lot number is 410420, and the UDI is (01) 0 0880304 53246 5 (17) 290825 (10) 410420. The distribution pattern is listed as international distribution to the Netherlands.

Healthcare providers and patients should check their inventory for this specific item number and lot number. If the packaging contains two baseplates and no taper adapters, the product should be removed from use and returned to Biomet, Inc. according to their instructions.

The recalled product

Product
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
Manufacturer
Biomet, Inc.
Affected units
21

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 Number: 410420 UDI: (01) 0 0880304 53246 5 (17) 290825 (10) 410420

Distribution

Distribution scope not specified by the agency.