Device 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.
Z-2338-2016
Product summary
- Event
- Event 74636
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-2338-2016
Official wording
Reason: The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Code information: Lot # 61999884, Serial # N/A Lot # 62267513, Serial # N/A Lot # 62635782, Serial # N/A
Distribution pattern: 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.
Derived failure modes
-
Unknown
The surface coating applied to the device is blistering, peeling and discoloring after usage over time