Recall Z-1483-2013 ยท GFD Dermatome
Zimmer Surgical Inc
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
| Date | Jun 5, 2013 (initiated May 7, 2013) |
| Status | Terminated |
| Reason | This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site. |
| Root cause | Process control |
| Action | The firm, Zimmer, sent an "URGENT: DEVICE REMOVAL" notice dated May 7, 2013, to all consignees/customers via FED Ex and Distributors via E-mail. Consignees who had devices repaired received telephone calls as well as the mailed Recall Notice. The Notice identified the devices being recalled; possible adverse events and directions to immediately stop use of and remove affected product, and obtain an RGA (Return Goods Authorization) number by calling (800)348-2759 or email information to dover.repairs@zimmer.com . to return the devices for repair to:Zimmer Surgical, Attn: QA/RA Dept.- Recall, |
| Quantity | 84 units |
| Distribution | Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.