The Recall Desk
ModerateFDA (Devices)·Z-1208-2015·Announced 2015-03-04

Biomet Shoulder Implant Recall Due to Missing Taper Adaptor

Biomet is recalling specific shoulder implant baseplates because a taper adaptor is missing from the packaging, which may delay surgery.

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, but the hazard is a logistical delay in surgery rather than a direct physical injury or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet, Inc. is recalling the Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number 010000589, Lot 527400. The recall involves 11 units, of which 6 have been consumed and 5 remain with distributors. The products were distributed domestically in Alabama, Florida, New York, and Texas.

The recall is being issued because the taper adaptor is missing from the packaging. This defect may result in a delay in surgery greater than 30 minutes. No injuries or illnesses have been reported in connection with this recall.

Healthcare providers and distributors should stop using the affected units and contact Biomet, Inc. for further instructions. Patients who have already received the implant should contact their surgeon if they have concerns regarding their specific surgical procedure.

The recalled product

Product
Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
Manufacturer
Biomet, Inc.

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)

  • Part Number: 010000589 Lot: 527400

Distribution

Distributed in 4 states: