Zimmer¿ Air Dermatome II Handpiece — Class II medical device recall Z-2334-2016
Terminated recall by Zimmer Surgical Inc, reported 2016-08-10, distributed nationwide. The surface coating applied to the device is blistering, peeling and discoloring after usage over time
| Recall number | Z-2334-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Surgical Inc, Dover, OH, United States |
| Recall initiated | 2016-07-04 |
| Classified | 2016-08-04 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2017-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 630 units |
| Lot numbers | 61977101, 61980678, 61989398, 62008619, 62083340, 62096333, 62122378, 62191658, 62191665, 62220857, 62220882, 62244236, 62266024, 62267510, 62267596, 62289834, 62309628, 62309698, 62369392, 62374685, 62374721, 62393971, 62394012, 62454338, 62476761, 62494048, 62494086, 62525837, 62554526, 62578715, 62578759, 62635778 |
| Serial numbers | 500001, 500019, 500021, 500040, 500081, 500090, 500091, 500110, 500151, 500170, 500171, 500190, 500191, 500210, 500211, 500230, 500231, 500250, 500251, 500270, 500291, 500310, 500331, 500350, 500351 and 39 more |
| Model numbers | 00-8851-001-00 |
Product
Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. 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 for recall
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2334-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.