Zimmer Air Dermatome II Recalled Due to Broken Planetary Gear Teeth
Zimmer Surgical Inc is recalling 126 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently.
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. The hazard involves device malfunction leading to surgical delays or suboptimal results, but no injuries, hospitalizations, or deaths are reported in the source text.
Plain-English summary
Zimmer Surgical Inc is recalling 126 units of the Zimmer Air Dermatome II handpiece, reference number 00-8851-001-00. These are prescription, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities. The affected units were distributed worldwide, including the United States, Puerto Rico, and various international locations such as Canada, Australia, and several countries in Europe and Asia.
The recall is in response to complaints alleging that the devices 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 surgery or result in suboptimal graft retrieval, potentially requiring an additional donor site.
Healthcare facilities and users should stop using the affected units and contact Zimmer Surgical Inc for further instructions. The specific serial numbers affected are listed in the official recall notice.
The recalled product
- Product
- Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
- Manufacturer
- Zimmer Surgical Inc
- Affected units
- 126
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 (20)
- Serial Number 500191
- 500192
- 500193
- 500194
- 500196
- 500197
- 500198
- 500199
- 500200
- 500201
- 500202
- 500203
- 500204
- 500205
- 500206
- 500207
- 500208
- 500209
- 500210
- 500211
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
- ModerateA.T.S. 3200TS tourniquets recalled over screens that may freeze
FDA (Devices) · 2026-02-04
- ModerateTourniquet systems recalled over screens that may freeze in non-English settings
FDA (Devices) · 2026-02-04
- ModerateDermatome AN units recalled because the thickness control bar may be misaligned
FDA (Devices) · 2025-12-24
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateZimmer Air Dermatome II Handpieces Recalled for Surface Coating Defects
FDA (Devices) · 2016-08-10
- ModerateZimmer Air Dermatome II Handpiece Recalled for Surface Coating Defects
FDA (Devices) · 2016-08-10
- ModerateZimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects
FDA (Devices) · 2016-08-10
- HighZimmer Dermatome Blades recalled for producing thin, non-uniform skin grafts
FDA (Devices) · 2023-10-11
- HighZimmer Dermatone AN Skin Graft Device Recalled for Loose Control Bar
FDA (Devices) · 2018-08-08
- ModerateAir dermatomes recalled because the thickness control bar may be misaligned
FDA (Devices) · 2025-12-24