REF 70-0074-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, ROSETTE, SERRATED, STRAIGHT, STERILE, Rx ONLY. CONMED LINVATEC, 11311

FDA device recall Z-2258-2010 · posted 2010-08-24 · Terminated

Recall details

Recalling firm

Linvatec Corp. dba ConMed Linvatec

Reason for recall

This recall was due to the possibility that multiple products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents.

Action taken

Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.

Root cause

Material/Component Contamination

Status

Terminated

Product code

HRX

Quantity affected

35,451 total

Distribution

Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Re

Date initiated

2010-01-28

Date posted

2010-08-24

Date terminated

2010-12-15

Location

Largo, FL