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U.S. Department of Health and Human Services

Class 2 Device Recall UniCP Compression Forceps (spreader)

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 Class 2 Recall
UniCP Compression Forceps (spreader)
see related information
Date Posted December 01, 2008
Recall Status1 Terminated on May 11, 2009
Recall Number Z-0307-2009
Recall Event ID 49561
Premarket Notification
510(K) Number
K070447 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number: 339001ND Newdeal, Lyon, France; Integra, 411 Enterprise Drive, Plainsboro, NJ 08536 Intended to open the UNI-Compression Plate olive, which creates a compression.
Code Information Lot numbers E6WS, E7UY and E86M.
Recalling Firm/
Manufacturer
Integra LifeSciences Corp
105 Morgan Ln
Plainsboro, New Jersey 08536-3339
For Additional Information Contact Sean Luland
609-275-2700
Manufacturer Reason
for Recall
Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Recall Notice letters were sent to all Integra Sales Specialists on September 30, 2008 by first class mail. The letter informed them of the product and the problem concerning the product. The Sales Specialists were asked to return all inventories under their control with part number 339001ND from lots E6WS, E7UY, & E86M. They are required to fill out the attached form identifying the lot number for all Newdeal Compression Forceps (Spreader) in their inventory along with the serial number(s) of their Uni-CP set(s). The form should be filled out even if the sales specialist does not have a Uni-CP. The form should be faxed or mailed back to Walt Ryan in Customer Service, 609-799-3297. A RMA number will be generated for the return of any affected inventory. A replacement will be sent and upon receipt, the forceps (spreader) should be replaced and returned to the address indicated on the letter.
Quantity in Commerce 90
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = NEWDEAL SAS
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