Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121H QTY 1 3.5 x 10.
FDA device recall Z-1548-05 · posted 2005-09-21 · Terminated
Recall details
- Recalling firm
- Linvatec Corp.
- Reason for recall
- Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for compromised sterility of the devices.
- Action taken
- Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 289 Units
- Distribution
- Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates).
- Date initiated
- 2005-02-22
- Date posted
- 2005-09-21
- Date terminated
- 2012-07-07
- 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 |
|---|---|---|
| BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE (K042778) | Linvatec Corp. | 2004-11-04 |