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.
Enforcement
- Recall Number
- Z-2338-2016
- Event ID
- 74636
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer Surgical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- August 10, 2016
- Initiation Date
- July 4, 2016
- Classification Date
- August 4, 2016
- Termination Date
- June 21, 2017
- Address
- 200 W Ohio Ave, Dover, OH, 44622-9642, United States
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.
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Lot # 61999884, Serial # N/A Lot # 62267513, Serial # N/A Lot # 62635782, Serial # N/A
US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
60 units