Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthe
FDA device recall Z-0907-06 · posted 2006-05-27 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc.
- Reason for recall
- The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations.
- Action taken
- Customer notification letter was sent out on 3/28/2006 alerting the customer to the problem with the suture.
- Root cause
- Other
- Status
- Terminated
- Product code
- GAM
- Quantity affected
- 1,061,712 sutures
- Distribution
- There were 2202 customers in the US and 10 international customers. This product is no longer being marketed by Ethicon. Its last shipment was 7/1/2002. There are US Military and VA Hospitals included
- Date initiated
- 2006-02-16
- Date posted
- 2006-05-27
- Date terminated
- 2006-12-07
- 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 |
|---|---|---|
| PANACRYL (K974299) | ETHICON, Inc. | 1998-02-13 |
| ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED (K964345) | ETHICON, Inc. | 1996-12-16 |