GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only.
FDA Recall Z-2503-2010 · Posted 2010-09-25
Recalling FirmLinvatec Corp. dba ConMed Linvatec
Recall StatusTerminated
Product CodeGFA
Date Initiated2010-08-05
Date Terminated2010-12-14
Product Quantity174
Reason for Recall
ConMed Linvatec, Largo, FL is recalling ConMed Linvatec 9263A,4.2mm Sterling Blade, Gator Meniscus Cutter, Lot Number 178026 for breech in the sterile barrier.
Firm Action
Recall Notifications will be sent to all direct consignees by FedEx, email, Fax, etc. If the account no longer has the product in their possession, they will be asked to respond as such. A Return Material Authorizations Number will be assigned for the returned product as required. Product returned will be placed into quarantine and will be dispositioned in accordance with ConMed Linvatec procedures.
100% of the consignees will be contacted. The reply form is the mechanism to verify notification effectiveness to all consignees. If a reply is not received within approximately 30 business days of the first notification ConMed Linvatec will make two additional contacts by phone and / or email, as necessary, to insure all consignees have received notification and have taken appropriate action. If a reply is not received following the third contact by email or phone, no further contacts will be made to the consignee.
Root Cause
Packaging process control
Distribution Pattern
Products were distributed to ConMed Linvatec consignees, sales representatives and affiliates within the US and Australia. US distribution was to WA, AZ, PA, KS, NM, UT, ID, IL. Products were distributed to ConMed Linvatec Australia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.