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.
Recall
- Recall Number
- Z-0307-2009
- Event Number
- 49561
- Firm
- Integra LifeSciences Corp
- FEI Number
- 1121308
- Product Code
- HRS
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 30, 2008
- Posted
- December 1, 2008
- Terminated
- May 11, 2009
- Address
- 105 Morgan Ln, Plainsboro, NJ, 08536-3339
Description
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.
Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate
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.
Nationwide Distribution
90