Recall Z-0711-2008 ยท GFF Bur, Surgical, General & Plastic Surgery
Linvatec Corp.
ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773
| Date | Apr 8, 2008 (initiated Aug 9, 2007) |
| Status | Terminated |
| Reason | Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal. |
| Root cause | Packaging process control |
| Action | Conmed Linvatec sent their consignees Urgent New Recall Medical Device Recall Notification letters On August 9, 2007 by UPS overnight delivery. The letter requests the customer return the devices to Linvatec for credit. Domestic Distributors / Sales Representatives were notified by telephone and email. |
| Quantity | 1181 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K781979 | SURGAIRTOME TWO American Sterilizer Co., Dec 20, 1978 |