Z-2335-2016 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
- 220 units
Product Description
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 is packed with the handpiece between the top foam pad and box lid. 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 # 61987607, Serial # 500041 500060 Lot # 61989397, Serial # 500061 500080 Lot # 62007988, Serial # 500111 500130 Lot # 62008620, Serial # 500131 500150 Lot # 62244213, Serial # 500311 500330 Lot # 62267555, Serial # 500392 500411 Lot # 62289845, Serial # 500432 500451 Lot # 62309684, Serial # 500492 500511 Lot # 62374706, Serial # 500572 500591 Lot # 62393940, Serial # 500612 500631 Lot # 62415890, Serial # 500672 500691