Recall Z-0307-2009 ยท HRS Plate, Fixation, Bone
Integra LifeSciences Corp
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.
| Date | Dec 1, 2008 (initiated Sep 30, 2008) |
| Status | Terminated |
| Reason | Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate |
| Root cause | Nonconforming Material/Component |
| 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 U |
| Quantity | 90 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070447 | NEWDEAL COMPRESSION PLATE Newdeal Sas, Mar 29, 2007 |