"***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***S

FDA device recall Z-2703-2011 · posted 2011-06-29 · Terminated

Recall details

Recalling firm

Linvatec Corp. dba ConMed Linvatec

Reason for recall

ConMed Linvatec, Largo, FL is recalling CrossFT Suture Anchor with Two #2 HI-Fi sutures, Lot 211581, Product Number CFP-5502. There is a possibility that the product may have been incorrectly assembled. The disposable driver may have the incorrect color handle (red versus black).

Action taken

ConMed Linvatec sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated January 27, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to check their inventory for affected lots and return for credit. A Reply Form and FedEx Air bill was enclosed with the letter for customers to complete and return with the product. Questions regarding the recall can be answered by contacting the Customer Service Department via e-mail at Custserv1@linvatec.com.

Root cause

Employee error

Status

Terminated

Product code

MBI

Quantity affected

45 each

Distribution

Worldwide Distribution--USA (nationwide) and countries of Canada and South Africa.

Date initiated

2011-01-26

Date posted

2011-06-29

Date terminated

2011-07-18

Location

Largo, FL