Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. 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: The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Code information: Lot # 61977101, Serial # 500001  500019 Lot # 61980678, Serial # 500021  500040 Lot # 61989398, Serial # 500081  500090 Lot # 62008619, Serial # 500091  500110 Lot # 62083340, Serial # 500151  500170 Lot # 62096333, Serial # 500171  500190 Lot # 62122378, Serial # 500191  500210 Lot # 62191658, Serial # 500211  500230 Lot # 62191665, Serial # 500231  500250 Lot # 62220857, Serial # 500251  500270 Lot # 62220882, Serial # 500291  500310 Lot # 62244236, Serial # 500331  500350 Lot # 62266024, Serial # 500351  500371 Lot # 62267510, Serial # 500372  500391 Lot # 62267596, Serial # 500452  500471 Lot # 62289834, Serial # 500412  500431 Lot # 62309628, Serial # 500472  500491 Lot # 62309698, Serial # 500512  500531 Lot # 62369392, Serial # 500532  500551 Lot # 62374685, Serial # 500552  500571 Lot # 62374721, Serial # 500592  500611 Lot # 62393971, Serial # 500632  500651 Lot # 62394012, Serial # 500652  500671 Lot # 62454338, Serial # 500692  500711 Lot # 62476761, Serial # 500712  500731 Lot # 62494048, Serial # 500732  500751 Lot # 62494086, Serial # 500752  500771 Lot # 62525837, Serial # 500772  500791 Lot # 62554526, Serial # 500792  500811 Lot # 62578715, Serial # 500812  500831 Lot # 62578759, Serial # 500832  500851 Lot # 62635778, Serial # 500852  500871

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.