Zimmer Biomet Recalls Intramedullary Bone Saw Cam Assemblies Due to Sizing Error
Zimmer Biomet is recalling 34 units of 14MM Intramedullary Bone Saw Cam Assemblies because some were labeled as 14MM but measured as 13MM.
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 surgical instrument with a dimensional discrepancy (13MM vs 14MM) which poses a risk of harm during surgery, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 34 units of Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM (Item Number: 475665). The recall is due to a possible commingle where an assembly was labeled and etched as a 14MM unit but actually measured as a 13MM cam.
The affected units are distributed to US states of CA, FL, IN, MN, MO, NY, and UT, as well as Australia and New Zealand. The specific lot numbers involved are 334360, 366680, and 366670.
Healthcare facilities and consumers should stop using these specific units and contact Zimmer Biomet for further instructions or replacement.
The recalled product
- Product
- Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 34
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 Numbers: 334360
- 366680
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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