| Class 2 Device Recall Surgical Bit | |
Date Initiated by Firm | April 10, 2012 |
Date Posted | November 19, 2012 |
Recall Status1 |
Terminated 3 on November 21, 2013 |
Recall Number | Z-0384-2013 |
Recall Event ID |
63077 |
Product Classification |
Bit, drill - Product Code HTW
|
Product | "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***".
This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction. |
Code Information |
S8585 (8.5MM Drill Bit), lot number 322287 |
Recalling Firm/ Manufacturer |
Linvatec Corp. dba ConMed Linvatec 11311 Concept Blvd Largo FL 33773-4908
|
For Additional Information Contact | 727-392-6464 |
Manufacturer Reason for Recall | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package. |
FDA Determined Cause 2 | Labeling Change Control |
Action | ConMed/Linvatec sent an Urgent Medical Device Recall Notificaiton letter via phone and FedEx on April 9, 2012 and again on May 11, 2012, to all affected customers. They also sent the same Notification on May 14, 2012, to international accounts. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete a reply formand fax it to 727-319-5701. Customers were also instructed to return all affected product to the firm. All returned product under this removal action will be identified, segregated and quarantined per firm procedures, etc.
Customers with questions should contact Customers Service at Custserv@linvatec.com.
For questions regarding this recall call 727-392-6464. |
Quantity in Commerce | 70 total |
Distribution | Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania. |
Total Product Life Cycle | TPLC Device Report |
|
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.
|
|
|
|