Z-2337-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 10, 2016
- Initiation Date
- July 4, 2016
- Termination Date
- June 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 units
Product Description
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 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
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.
Code Information
Lot # 61999885, Serial # N/A Lot # 62267472, Serial # N/A Lot # 62339198, Serial # N/A Lot # 62629006, Serial # N/A