C-REAMER CANNULATED, STERILE, Rx ONLY. REF 8772A, 9.0MM, QTY DIST 712. REF 8773A, 10MM, QTY DIST 1,244. REF 8774A, 11MM, QTY DIST 384 REF 8775A, 12MM, QTY DIST 156 CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
FDA Recall Z-2252-2010 · Posted 2010-08-24
Recalling FirmLinvatec Corp. dba ConMed Linvatec
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-01-28
Date Terminated2010-12-15
Product Quantity35,451 total
Reason for Recall
This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents.
Firm Action
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
Distribution Pattern
Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Republic of Korea, Netherlands, Portugal, Serbia, Singapore, Slovenia, El Salvador, Thailand, Taiwan, South Africa, and throughout the U.S.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.