Recall Z-0955-2011 ยท HRS Plate, Fixation, Bone
Integra LifeSciences Corp.
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.
| Date | Jan 25, 2011 (initiated Nov 18, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |