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U.S. Department of Health and Human Services

Class 2 Device Recall UniCP Compression Plate System

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  Class 2 Device Recall UniCP Compression Plate System see related information
Date Initiated by Firm November 18, 2010
Date Posted January 25, 2011
Recall Status1 Terminated 3 on November 18, 2011
Recall Number Z-0955-2011
Recall Event ID 57380
510(K)Number K091609  K070447  
Product Classification Plate, fixation, bone - Product Code HRS
Product Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC

The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction.
Code Information Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact
609-275-0500
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce Sixty seven (67) Kits
Distribution Nationwide distribution: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.
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.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = NEWDEAL SAS
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