Zimmer Dermatone AN, Model No. 88710100
Recall
- Recall Number
- Z-2602-2018
- Event Number
- 80466
- Firm
- Zimmer Surgical Inc
- FEI Number
- 1526350
- Product Code
- GFD
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- June 8, 2018
- Terminated
- July 19, 2019
- Address
- 200 W Ohio Ave, Dover, OH, 44622-9642
Description
Zimmer Dermatone AN, Model No. 88710100
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.
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 [email protected] 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 [email protected]. 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 [email protected].
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.
140