Biomet Recalls Orthopedic Implants Due to Screw Hole Mismatch
Biomet is recalling 634 Zimmer Biomet Comprehensive Segmental Revision System implants because a screw hole mismatch may prevent proper assembly during 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. The hazard involves a mechanical assembly issue with an estimated occurrence rate of less than 1%, and no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet, Inc. is recalling 634 units of the Zimmer Biomet Comprehensive Segmental Revision System (SRS) orthopedic implants. These products are used for proximal, distal, and total humeral reconstruction. The recall covers specific model numbers and lots distributed nationwide in the United States.
The recall was initiated because an SRS Humeral Distal Body implant failed to engage correctly with a Discovery Elbow System Humeral Condyle during assembly. This mismatch between the screw holes in the Humeral Body and the Elbow Condyle affects assembly during surgery. The company estimates that this mismatch prevents screw engagement in less than 1% of cases.
If the product has already been implanted, no action is required. Consumers and healthcare providers should check their inventory against the specific model numbers and lot codes listed in the official recall notice to identify affected units.
The recalled product
- Product
- Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
- Manufacturer
- Biomet, Inc.
- Affected units
- 634
Distribution
Distributed nationwide across the United States.
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