Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number: 339001ND Newdeal, Lyon, France; Integra, 411

FDA device recall Z-0307-2009 · posted 2008-12-01 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp

Reason for recall

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

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HRS

Quantity affected

90

Distribution

Nationwide Distribution

Date initiated

2008-09-30

Date posted

2008-12-01

Date terminated

2009-05-11

Location

Plainsboro, NJ

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