Zimmer Biomet Recalls 13MM Intramedullary Bone Saw Cam Assemblies
Zimmer Biomet is recalling 26 units of 13MM Intramedullary Bone Saw Cam Assemblies due to possible commingling with 14MM units.
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 risk-of-harm product (surgical instrument) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 26 units of the Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM (Item Number: 475660). The recall is due to a possible commingling issue where an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM unit but measured as a 13 MM 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 025800, 025810, and 081640.
Healthcare facilities and consumers should stop using the affected products and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 26
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: 025800
- 025810
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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