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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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