Drug recall
Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and…
FDA recall event 74636 · Class II · Zimmer Surgical Inc
Key facts
| Event ID | 74636 |
|---|---|
| Recall numbers | Z-2334-2016, Z-2335-2016, Z-2336-2016, Z-2337-2016, Z-2338-2016, Z-2339-2016, Z-2340-2016 |
| Recalling firm | Zimmer Surgical Inc |
| Product type | Devices |
| Products | 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…, 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…, Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates…, Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width…, Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when… and 2 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The surface coating applied to the device is blistering, peeling and discoloring after usage over time |
| Initiation date | Jul 4, 2016 |
| Report date | Aug 10, 2016 |
| Termination date | Jun 21, 2017 |
| City | Dover |
| State | OH |
| Country | United States |
| FEI number | 1526350 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: