Zimmer Biomet Recalls Nondegradable Soft Tissue Fixation Fasteners
Zimmer Biomet is recalling 429 units of nondegradable soft tissue fixation fasteners because the implant shaft may shift and fall out during device opening.
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 mechanical defect that could cause the device to break during use, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 429 units of nondegradable soft tissue fixation fasteners. The recall involves specific item and lot numbers distributed to facilities in Texas, North Carolina, Florida, Pennsylvania, Indiana, Wisconsin, Virginia, New York, New Jersey, Alabama, and Connecticut.
The recall was initiated because the product was not assembled correctly. This defect causes the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
Healthcare providers and consumers should stop using the affected fasteners and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- fastener, fixation, nondegradable, soft tissue
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 429
Distribution
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