Zimmer® Air Dermatome and Zimmer® Dermatome AN handpieces
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Zimmer® Dermatome AN Handpiece | More than 10 numbers, contact manufacturer. | 88710100 |
| Zimmer® Air Dermatome | More than 10 numbers, contact manufacturer. | 00-8801-001-00 |
Issue
Zimmer Biomet is conducting a phased serial specific medical device recall for the Zimmer® Air Dermatome and Zimmer® Dermatome AN handpieces. Multiple complaints have been received related to dermatome devices that were cutting beyond the proper depth. Five complaints have been reported in Canada, they are CMP-0960689, CMP-0969102, CMP-0973010, CMP-0984249 and CMP-0987024. Inspections of the returned complaint devices confirmed that affected devices may have a misaligned thickness control bar. If the device has a misaligned thickness control bar from manufacture, it would be expected to manifest such that any potential negative outcomes would be present upon the first few uses. All devices manufactured between March 2023 and April 2025, that have not been returned for repair or preventive maintenance, are within scope of the recall. The defectiveness was discovered on June 18, 2025. Issue was identified through the complaints handling process.
Additional information
Details
Zimmer Surgical, Inc. Also Trading As Relign Corporation
200 W Ohio Avenue, Dover, Ohio, United States, 44622
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