Z-0307-2009

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

Name: Z-0307-2009 Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number: 339001ND Newdeal, Lyon, France...
Creator: Integra LifeSciences Corp
Published: 2008-09-30
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2008-09-30 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp began a recall of Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number: 339001ND Newdeal, Lyon, France; Integra, 411 Enterprise Drive, Plainsboro, NJ 08536... on 2008-09-30. The reason FDA records is "Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0307-2009
Status: Terminated
Initiated: 2008-09-30
Posted: 2008-12-01
Terminated: 2009-05-11
Recalling firm: Integra LifeSciences Corporation
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.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 90
Distribution: Nationwide Distribution
Product codes and lots: Lot numbers E6WS, E7UY and E86M.

Product code HRS

K070447Class IINewdeal Compression PlateNewdeal Sas / cleared 2007-03-29

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)