—#147962

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.

FDA product code: KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K140463
Affected lot / code info: Lot # PN625.

Why it was recalled

The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.

Timeline

Recall initiated: 2016-07-01
Terminated: 2016-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147962. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.