Z-0308-2011

Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package. The PANTA(R) Nail is...

Name: Z-0308-2011 Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package. The PANTA(R) Nail is...
Creator: Integra LifeSciences Corporation
Published: 2010-03-01
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2010-03-01 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corporation began a recall of Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package. The PANTA(R) Nail is intended for use in tibiotalocalcaneal arthrodesis... on 2010-03-01. The reason FDA records is "Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (Panta Support Device)". 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-0308-2011
Status: Terminated
Initiated: 2010-03-01
Posted: 2010-11-02
Terminated: 2012-02-16
Recalling firm: Integra LifeSciences Corporation
Product: Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package. The PANTA(R) Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (Panta Support Device).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: OIntegra issued Urgent Product Recall Notification letters dated 3/1/2010 to customers and distributors to notify them of the problem. Customers were requested to check their inventory to determine if they have an of the affected devices. If so, custo0mers should stop using the product. Custoemrs with the affected product should contact their local Sales Representative for assistance, or contact Integra at 800-654-2873 - 3 to obtain a returned material authorization number, and return the product to their local representative. All customers were requested to complete and return a Recall Acknowledgement and Return Form..
Quantity in commerce: 108 Units
Distribution: Worldwide distribution: USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, VA, WA and WI; and countries of: Australia, Austria, Belgium, Czech Republica, Denmark, Finland, France, Germany, Ireland, Italy, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
Product codes and lots: Catalog number 519110, Kit S/N: PAN-001, PANTAXL-015; PAN-003, PANTAXL-017; PAN-004, PANTAXL-019; PAN-006, PANTAXL-020; PAN-013, PANTAXL-022; PAN-016, PANTAXL-026; PAN-018, PANTAXL-029; PAN-021, PANTAXL-031; PAN-023, PANTAXL-032; PAN-024, PANTAXL-033; PAN-025, PANTAXL-034; PAN-027, PANTAXL-035; PAN-030, PANTAXL-036; PAN-038, PANTAXL-039; PANTAXL-008, PANTAXL-040; PANTAXL-011, PANTAXL-042 & PANTAXL-012

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