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.
This recall has been terminated (originally issued December 1, 2008).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- September 30, 2008
- Posted
- December 1, 2008
- Terminated
- May 11, 2009
- Recall Number
- Z-0307-2009
- Quantity
- 90
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate
Distribution
Nationwide Distribution
Lot / Code Info
Lot numbers E6WS, E7UY and E86M.
Root Cause
Nonconforming Material/Component
Action Taken
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.