| | Class 2 Recall
Uni-CP Compression Forceps (spreader) |  |
| Date Posted |
December 01, 2008 |
| Recall Number |
Z-0307-2009 |
| 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
|
Reason for
Recall |
Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate
|
| 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 |
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