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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Air Dermatome II Handpiece w/o Hose

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  Class 2 Device Recall Zimmer Air Dermatome II Handpiece w/o Hose see related information
Date Initiated by Firm July 04, 2016
Date Posted August 04, 2016
Recall Status1 Terminated 3 on June 21, 2017
Recall Number Z-2335-2016
Recall Event ID 74636
Product Classification Dermatome - Product Code GFD
Product 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.
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 
Recalling Firm/
Manufacturer		 Zimmer Surgical Inc
200 W Ohio Ave
Dover OH 44622-9642
For Additional Information Contact
330-343-8801
Manufacturer Reason
for Recall		 The surface coating applied to the device is blistering, peeling and discoloring after usage over time
FDA Determined
Cause 2		 Process design
Action 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.
Quantity in Commerce 220 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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