Zimmer Air Dermatome II Recalled Due to Broken Planetary Gear Teeth
Zimmer Surgical Inc is recalling 13 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently during surgery.
What this means for you
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 is classified as FDA Class II. The hazard involves a risk of harm (surgery delay, suboptimal graft, additional donor site) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Surgical Inc is recalling 13 units of the Zimmer Air Dermatome II handpiece (REF 00-8851-001-01). The affected devices are non-sterile grafting instruments intended to provide variable graft thickness and width capabilities. The recall is in response to complaints alleging that the products would either not operate or operate intermittently.
Zimmer's investigation determined that the planetary gear teeth were broken. This defect may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with the potential of requiring an additional donor site.
The affected units were distributed worldwide, including the USA (nationwide including Puerto Rico), UAE, Taiwan, Sweden, Thailand, Korea, Singapore, Hong Kong China, Chile, Canada, Australia, Japan, England, Germany, and Egypt. The specific serial numbers affected are 500311, 500312, 500317, 500320, 500321, 500322, 500323, 500324, 500325, 500326, 500327, 500328, and 500329.
The recalled product
- Product
- Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities.
- Manufacturer
- Zimmer Surgical Inc
- Affected units
- 13
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 (13)
- Serial Number 500311
- 500312
- 500317
- 500320
- 500321
- 500322
- 500323
- 500324
- 500325
- 500326
- 500327
- 500328
- 500329
Distribution
Part of a larger recall action
This product is one of 3 recalled by Zimmer Surgical 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Zimmer Surgical Inc
See all →- ModerateSterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
FDA (Devices) · 2026-07-08
- ModerateSterile Tourniquet Hoses recalled for potential sterility breach
FDA (Devices) · 2026-07-08
- ModerateTourniquet systems recalled over screens that may freeze in non-English settings
FDA (Devices) · 2026-02-04
- ModerateA.T.S. 3200TS tourniquets recalled over screens that may freeze
FDA (Devices) · 2026-02-04
- ModerateAir dermatomes recalled because the thickness control bar may be misaligned
FDA (Devices) · 2025-12-24
Same hazard · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28