| Class 2 Device Recall ConMed Linvatec 9263A 4.2mm Sterling, Blade, Gator Meniscus Cutter |  |
Date Initiated by Firm | August 05, 2010 |
Date Posted | September 25, 2010 |
Recall Status1 |
Terminated 3 on December 14, 2010 |
Recall Number | Z-2503-2010 |
Recall Event ID |
56441 |
Product Classification |
Blade, Saw, General & Plastic Surgery, Surgical - Product Code GFA
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Product | GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only. |
Code Information |
Lot 178026 |
Recalling Firm/ Manufacturer |
Linvatec Corp. dba ConMed Linvatec 11311 Concept Blvd Largo FL 33773-4908
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For Additional Information Contact | Roger Murphy 727-392-6464 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 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. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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