| Class 2 Device Recall ARTHROKNIFE | |
Date Initiated by Firm | January 28, 2010 |
Date Posted | August 24, 2010 |
Recall Status1 |
Terminated 3 on December 15, 2010 |
Recall Number | Z-2251-2010 |
Recall Event ID |
54701 |
Product Classification |
Arthroscope - Product Code HRX
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Product | REF, 9973, 2.4mm ARTHROSCOPY KNIFE, BANANA STYLE, SMALL JOINT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for proper tissue dissection in small joint procedures. |
Code Information |
Lot Number: 64258, 95937, and 104470. |
Recalling Firm/ Manufacturer |
Linvatec Corp. dba ConMed Linvatec 11311 Concept Blvd Largo FL 33773-4908
|
For Additional Information Contact | Roger Murphy 727-392-6464 |
Manufacturer Reason for Recall | This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536. |
Quantity in Commerce | 35,451 total |
Distribution | Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Republic of Korea, Netherlands, Portugal, Serbia, Singapore, Slovenia, El Salvador, Thailand, Taiwan, South Africa, and throughout the U.S. |
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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