FDA Device recall Z-2335-2016
Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01
- FDA Device
- Class II
- terminated
- Published 2016-08-10
On 2016-08-10 the FDA classified a Class II recall of Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01 by Zimmer Surgical, citing the surface coating applied to the device is blistering, peeling and discoloring after usage over time.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2335-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-04 |
| Published | 2016-08-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Surgical |
| Distribution | US |
Product
Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
Reason
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Identifiers
| code_info | Lot # 61987607, Serial # 500041 500060 Lot # 61989397, Serial # 500061 500080 Lot # 62007988, Serial # 500111 …Lot # 61987607, Serial # 500041 500060 Lot # 61989397, Serial # 500061 500080 Lot # 62007988, Serial # 500111 500130 Lot # 62008620, Serial # 500131 500150 Lot # 62244213, Serial # 500311 500330 Lot # 62267555, Serial # 500392 500411 Lot # 62289845, Serial # 500432 500451 Lot # 62309684, Serial # 500492 500511 Lot # 62374706, Serial # 500572 500591 Lot # 62393940, Serial # 500612 500631 Lot # 62415890, Serial # 500672 500691 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2335-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.