Recall Z-2602-2018 ยท GFD Dermatome
Zimmer Surgical Inc
Zimmer Dermatone AN, Model No. 88710100
| Date | Jun 8, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 ea |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.