ConMed Linvatec 9263A 4.2mm Sterling, Blade, Gator Meniscus Cutter 의 리콜

Recall

56441

Class 2

Z-2503-2010

2010-08-05

2010-09-25

Terminated

United States

2010-12-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93673

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.

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.