Biomet Recalls Misidentified 9mm Shoulder Mini Humeral Stem Implants
Biomet is recalling 14 units of 9mm Shoulder Mini Humeral Stems that were misidentified as 15mm units. The error poses a risk of improper surgical implantation.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a labeling error that could lead to the use of an incorrect implant size, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 14 units of the Comprehensive Shoulder System Mini Humeral Stem 9mm, Model No. 113629. The recall is due to a labeling error where a 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm unit. The affected product is identified by Lot No. 659260 and UDI Number (1)00880304462649(17)290814(10)659260.
The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system. The misidentification could lead to the use of an incorrect implant size during surgery. The agency has classified this recall as Class II.
The affected units were distributed internationally in Canada, Japan, the Netherlands, and South Korea. Healthcare providers and facilities that have received these specific units should stop using them and contact Biomet, Inc. for instructions on return or replacement.
The recalled product
- Product
- Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.
- Manufacturer
- Biomet, Inc.
- Affected units
- 14
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 No. 659260
- UDI Number: (1)00880304462649(17)290814(10)659260
Distribution
Distribution scope not specified by the agency.
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