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U.S. Department of Health and Human Services

Class 2 Device Recall 87k Arthroscopy Tubing Set

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  Class 2 Device Recall 87k Arthroscopy Tubing Set see related information
Date Initiated by Firm July 06, 2010
Date Posted August 09, 2010
Recall Status1 Terminated 3 on February 24, 2011
Recall Number Z-2192-2010
Recall Event ID 56163
Product Classification Arthroscope - Product Code HRX
Product REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY. Warning: Do not use this tubing set with any Small Joint Cannula System.

CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Made in USA.

The 87K Arthroscopy Tubing Set is designed for use with the 87K Arthroscopy Pump System. This system can be used in arthroscopic procedures using fluid irrigation for joint distension. This system may be used where gravity systems are currently in use such as knee, shoulder, ankle and elbow arthroscopy.
Code Information Lot 0904151 through 1005201.
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
ConMed Linvatec Largo, FL is recalling 87K Arthroscopy Tubing Set, Product Number 87100, Lots 0904151 to and including 1005201. Product may have a breach in the seal that could potentially compromise the sterility of the contents.
FDA Determined
Cause 2
Process control
Action ConMed Linvatec Corporation sent an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 6, 2010, via FedEx next day delivery to all customers. The letter described the product, problem and action to be taken by customers within 30 days of receipt of the letter. The customers were asked to PLEASE DISCONTINUE USE OF THE IDENTIFIED PRODUCT WITH LOT NUMBERS BEGINNING WITH 0904151 THROUGH AND INCLUDING 1005201; to immediately check their inventory for the affected lots number and Do Not Use if they have any of the products; to complete and return a Reply Form and to notify their customers if the product was further distributed and return all unused affected product with lot codes starting 0904151 to and including 1005201, to ConMed Corporation, 525 French Road, Utica, NY 13502. On receipt, ConMed Linvatec will issue credit to customers. Should you have any additional questions, please contact our Customer Service department at 800-535-8536 or fax at 727-319-5701 or email: Custerserv1@linvatec.com
Quantity in Commerce 97,830
Distribution Worldwide distribution: USA and Canada.
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.
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