FDA-Device2025-12-24Class IIPROCESSING DEFECT
Zimmer Air Dermatome surgical device recalled for misaligned thickness control bar
What this means
Zimmer Surgical Inc. is recalling certain Zimmer Air Dermatome surgical devices because the thickness control bar may be misaligned. This could affect how the device operates during skin grafting procedures. No injuries have been reported so far.
- Check your device serial number against the affected lot codes (Lot Numbers 65944745, 65944748, 65944750, 65944752).
- Contact Zimmer Surgical Inc. for instructions on repair or replacement.
- Do not use the device if your serial number matches the recall list.
The agency's original wording
Hazard
The devices may have a misaligned thickness control bar.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distribution regions: USA, Hong Kong, Thailand, Japan, Korea, Australia, Taiwan, India, Malaysia, Singapore, China, Canada, EMEA, Mexico, Trinidad & Tobago, Panama, Guatemala Refer to the attached ZFA 2025-00141_Initial Consignee List and ZFA 2025-001141_Initial Distribution History containing the distribution and the identification of the domestic consignees.
Affected count
839 units
Manufactured in
200 W Ohio Ave, Dover, OH, United States
Products
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0924-2026More Zimmer Biomet recalls
- FDA-Device2026-07-08Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A
- FDA-Device2026-07-08Zimmer Surgical A.T.S. 4000 TS Tourniquet Hoses recalled for sterility breach risk
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