GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only.

FDA device recall Z-2503-2010 · posted 2010-09-25 · Terminated

Recall details

Recalling firm

Linvatec Corp. dba ConMed Linvatec

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.

Action taken

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

Status

Terminated

Product code

GFA

Quantity affected

174

Distribution

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 distribu

Date initiated

2010-08-05

Date posted

2010-09-25

Date terminated

2010-12-14

Location

Largo, FL