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.
This recall has been terminated (originally issued August 4, 2016).
- Company
- Zimmer Surgical Inc
- Recall Initiated
- July 4, 2016
- Posted
- August 4, 2016
- Terminated
- June 21, 2017
- Recall Number
- Z-2335-2016
- Quantity
- 220 units
- Firm Location
- Dover, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Distribution
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.
Lot / Code Info
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
Root Cause
Process design
Action Taken
The firm, Zimmer Biomet Surgical, sent an "URGENT MEDICAL DEVICE RECALL CORRECTION NOTICE" dated 7/6/2016 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Carefully review this letter and ensure all users of the Zimmer Air Dermatome II at your facility have been informed of this notice. 2. Inspect the Zimmer Air Dermatome II devices within your facility and indicate on the attached Certificate of Acknowledgment the condition of the device. Complete and sign the attached Certificate of Acknowledgment and return it to corporatequality.postmarket@zimmerbiomet.com. 3. Before each use, continue to examine the surface coating for blistering/peeling. If the blistering/peeling characteristics are not present, you may continue to use. Immediately after each use, re-examine the surface coating for blistering/peeling. If the blistering/peeling characteristics are present, discontinue use. In the event that alternate devices or therapies are not available, surgeons may, at their discretion, determine the use of the device as a medical necessity and continue to use. After use, follow your facilitys wound irrigation protocol or Zimmer Biomet recommends copious irrigation with a normal saline solution or immersion of the graft in a bowl of normal saline. Zimmer Biomet recommends irrigating the donor site with saline as well. Carefully examine the skin graft and donor site for gray coating flakes and continue to irrigate as necessary. Report this as an adverse event to Zimmer Biomet Surgical at SurgicalRegulatoryReporting@zimmerbiomet.com. If after reviewing this notification you have further questions or concerns please call 1-330-364-0989 between 8:00 am and 5:00 pm EST, Monday through Friday.