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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Dermatone ZN

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  Class 2 Device Recall Zimmer Dermatone ZN see related information
Date Initiated by Firm June 08, 2018
Create Date August 03, 2018
Recall Status1 Terminated 3 on July 19, 2019
Recall Number Z-2602-2018
Recall Event ID 80466
Product Classification Dermatome - Product Code GFD
Product Zimmer Dermatone AN, Model No. 88710100
Code Information Lots 63578134 , 63578135, 63592351, 63618116, 63646910, 63817639, 63898373 
Recalling Firm/
Manufacturer		 Zimmer Surgical Inc
200 W Ohio Ave
Dover OH 44622-9642
For Additional Information Contact Customer Service
800-830-0970
Manufacturer Reason
for Recall		 Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, could result in an imperfect, yet still usable graft. Potential risks include harvesting a skin graft of a thickness much greater than intended, described as patient gouged, minor delay of surgery, and sub-optimal (but usable) graft.
FDA Determined
Cause 2		 Under Investigation by firm
Action On June 8, 2018, the firm distributed an Urgent Medical Device Recall letter to affected consignees. The letter alerted customers to the issue. Customers were asked to do the following: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your facility. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. c. Request an RGA number for each unit by calling 800-830-0970 or emailing dover.repairs@zimmerbiomet.com. d. Include a copy of Attachment 3  Certificate of Sterilization with returned instruments. e. Mark RECALL and RGA Number on the outside of the returned cartons. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 800-830-0970 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 140
Distribution Distributors in AL, AZ, CA, FL, IA, IL, MA, MI, MN, MS, NH, NJ, NY, OH, RI, SD, and TX. Foreign distribution to Canada, Australia, China, and Netherlands.
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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