Device Recall UniCP Compression Plate System 의 리콜

Recall

57380

Class 2

Z-0955-2011

2010-11-18

2011-01-25

Terminated

United States

2011-11-18

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96421

Integra lifesciences corporation has decided to initiate a voluntary recall of the uni-comp kits due to inaccurate information relative to the recommended sterilization parameters described in the products instructions for use (ifu). the sterilization parameters noted in the uni-comp ifu were incorrect. it is noted that the sterilization recommendations in the uni-comp ifu in which the exposure.

The firm, Integra, contacted the Sales Representatives on November 8, 2010 via telephone conference calls. Integra also sent a "URGENT: PRODUCT RECALL NOTIFICATION" letter dated November 9, 2010 all customers via FedEx overnight delivery. The letter described the product, problem and the action to be taken by the customers and the firm. The customers were instructed to immediately examine their inventory, QUARANTINE THE PRODUCT, and complete and return the RECALL ACKNOWLEDGMENT AND RETURN FORM via mail: Integra LifeSciences Corporation, Attn: Sandy Yates, 311 Enterprise Drive, Plainsboro, NJ 08536, fax to (609)-275-5363 or Scan and email to sandra.yates@integralife.com. The firm will have a Integra LifeSciences Corporation Sales Representative contact the customer to assist them in retrieving and returning their Uni-CP Compression Plate System to Integra. Integra will also ship replacement Uni-CP Compression Plate (Uni-CPII and Large Uni-Clip) Systems back to the customers as soon as possible at no charge. Should you have any additional questions, contact the Director of Marketing, Hindfoot-Extremity Reconstruction or your regional managers at 513-533-7929, 609-275-0500 or toll free at 800-654-2873.