Recall Z-2338-2016— Zimmer Surgical Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2016-07-04, terminated 2017-06-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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, 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.
- Recalling firm
- Zimmer Surgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-04
- Terminated
- 2017-06-21
- Firm location
- Dover, OH, United States
Product description
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, 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.