Z-2296-2016Class II

Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions...

Name: Z-2296-2016 Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions...
Creator: Integra LifeSciences Corp.
Published: 2016-07-01
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2016-07-01 / Terminated / root cause: design

FDA source

Integra LifeSciences Corp. began a recall of Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external... on 2016-07-01. FDA classified it as Class II and gives the reason as "The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2296-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Posted: 2016-07-27
Terminated: 2016-12-16
Recalling firm: Integra LifeSciences Corporation
Product: Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
Root cause tag: design
FDA root cause: Device Design
Action: All affected consignees were notified via an "Urgent: Voluntary Medical Device Recall" letter sent on 7/1/16. The letter identified the affected product as well as the reason for the recall. Customers were asked to check their traceability records for shipments of the affected product. If the affected parts are found, customers are to stop use and distribution. A copy of the letter should be provided to any customers that the product may have been distributed to. The attached "Acknowledgement and Return Form" should be completed and returned regardless if customers have affected product or not. Questions regarding the instructions should be directed to Customer Service at 1-800-654-2873.
Quantity in commerce: 27 units
Distribution: Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
Product codes and lots: Lot # PN625.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2296-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2296-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-27

Product code KTT

K140463Class IIIntegra External Fixation SystemAscension Orthopedic / cleared 2014-10-10

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)