Zimmer Oscillating Saw Blade Recalled for Incorrect Width Labeling
Synvasive Technology is recalling 266 Zimmer oscillating saw blades because the label indicates a width of 25 mm, but the actual blade width is 19 mm.
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, and the hazard is a labeling error (incorrect width) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Synvasive Technology, Inc. is recalling 266 units of Zimmer Oscillating Saw Blades. These medical devices are intended for cutting bone or cartilage in orthopedic procedures. The recall was initiated because the product labels are incorrect: the label indicates a blade width of 25 mm, but the actual blade width is 19 mm.
The affected units were distributed in the United States to the states of Alabama and New York. The specific lot numbers and UDI codes for the recalled units are 265474, 304117, and 317918.
Healthcare providers and facilities that have received these products should stop using them and contact Synvasive Technology for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer
- Manufacturer
- Synvasive Technology Inc
- Hazard
- Affected units
- 266
Distribution
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