ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773
FDA device recall Z-0711-2008 · posted 2008-04-08 · Terminated
Recall details
- Recalling firm
- Linvatec Corp.
- Reason for recall
- Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GFF
- Quantity affected
- 1181 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2007-08-09
- Date posted
- 2008-04-08
- Date terminated
- 2009-10-01
- Location
- Largo, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGAIRTOME TWO (K781979) | American Sterilizer Co. | 1978-12-20 |