—#73813

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.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070447
Affected lot / code info: Lot numbers E6WS, E7UY and E86M.

Why it was recalled

Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp
Address: 105 Morgan Ln, Plainsboro, New Jersey 08536-3339

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2008-09-30
Posted by FDA: 2008-12-01
Terminated: 2009-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73813. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.