REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY. Warning: Do no

FDA device recall Z-2192-2010 · posted 2010-08-09 · Terminated

Recall details

Recalling firm

Linvatec Corp. dba ConMed Linvatec

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.

Action taken

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

Root cause

Process control

Status

Terminated

Product code

HRX

Quantity affected

97,830

Distribution

Worldwide distribution: USA and Canada.

Date initiated

2010-07-06

Date posted

2010-08-09

Date terminated

2011-02-24

Location

Largo, FL