Recall Z-2503-2010 ยท GFA Blade, Saw, General & Plastic Surgery, Surgical
Linvatec Corp. dba ConMed Linvatec
GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only.
| Date | Sep 25, 2010 (initiated Aug 5, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| 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 |
| Quantity | 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 distributed to ConMed Linvatec Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.