The Recall Desk
ModerateFDA (Devices)·Z-1676-2020·Announced 2020-04-15

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.

What this means for you

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
Affected units
266

Distribution

Distributed in 2 states:

Same manufacturer · Synvasive Technology Inc

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