Device Recall Sharpoint 40 Nylon Suture 의 리콜

Recall

58449

Class 3

Z-2138-2011

2011-03-30

2011-05-04

Terminated

United States

2011-08-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99373

Mislabeled - a number of units of the product labeled as 4-0 black mono nylon suture product contain a 4-0 black braided silk suture.

Surgical Specialites sent an Urgent Product Recall Notification letter on March 30, 2011, along with an attached Customer Acknowledgment Form to the affected consignees. It was reported that upon opening a box labeled as 4.0 Black Mono Nylon, it was observed that the package acutally contained 4-0 Black Braided Silk suture. Customers were to review their current inventory, segregate the affected lot number and / or contact their customer accounts that have purchased this specific item / lot code requesting a return of the product to customers' facility. To ensure customers have received this notification and to arrange for credit and the return of identified product, the Customer Acknowledgment Form should be completed and returned via fax to our Quality Assurance department at (610) 404-8488.