| Class 2 Device Recall UniCP Compression Plate System | |
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 | K070447 K091609 |
Product Classification |
Plate, fixation, bone - Product Code HRS
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = HRS
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