Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile
FDA device recall Z-1087-06 · posted 2006-06-02 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc.
- Reason for recall
- Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.
- Action taken
- The firm sent out recall notification on 5/4/2006. The US consignees were sent a letter via return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- GAM
- Quantity affected
- 1157 dozens
- Distribution
- Nationwide, Japan, Canada, and Taiwan.
- Date initiated
- 2006-05-04
- Date posted
- 2006-06-02
- Date terminated
- 2007-12-17
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COATED VICRYL* (POLYGLACTIN 910) SUTURE (K022269) | ETHICON, Inc. | 2002-09-13 |