Z-1877-2008

PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plainsboro, NJ. The...

Name: Z-1877-2008 PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plainsboro, NJ. The...
Creator: Integra LifeSciences Corp.
Published: 2008-03-24
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2008-03-24 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plainsboro, NJ. The Newdeal Ankle Nail is intended for use in... on 2008-03-24. The reason FDA records is "Certain PANTA Nails from one lot were incorrectly manufactured. The internal thread for certain PANTA Nails (Part Number 500050ND; Lot Number: E7XX) may present an insufficient depth and may not allow the engagement of...". 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-1877-2008
Status: Terminated
Initiated: 2008-03-24
Posted: 2008-09-16
Terminated: 2008-09-16
Recalling firm: Integra LifeSciences Corporation
Product: PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plainsboro, NJ. The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and the treatment of trauma to the hindfoot and distal tibia. The nail affords rigid, load sharing fixation that incorporates a simple nail-mounted, in-line method of compression across the arthrodesis site.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Certain PANTA Nails from one lot were incorrectly manufactured. The internal thread for certain PANTA Nails (Part Number 500050ND; Lot Number: E7XX) may present an insufficient depth and may not allow the engagement of the threaded part of the compression device. The risks presented include: an increase in surgery time, or the implantation of a nail less ideally suited for the patient's anatomy
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On March 24, 2008, Recall Notification Letters and Recall Acknowledgement Forms were sent to all Integra Sales Specialists to confirm products currently in their inventory and to place inventory on hold with no further shipments to customers. If you have any questions contact Judy O'Grady at (609) 936-2311.
Quantity in commerce: 45 units received in US, 22 were distributed.
Distribution: Class II Recall - Nationwide Distribution.
Product codes and lots: Catalog number 500050ND, Lot number: E7XX

Product code HSB

K050882Class IINewdeal Ankle NailNew Deal, S.A. / cleared 2005-05-27

MDM coverage of this record lists here, newest first.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)