—#74760

Product

T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by Howmedica, Osteonics Corp., 325 Corporate Drive, Mahwah, NJ

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number 1806-3213 and 18063211; Lot codes: K726345 and K679684

Why it was recalled

The thread of the nut which should fix the nail adaptor to the targeting arm may seize on the threat of the nail adaptor, interrupting surgery.

Root cause (FDA determination)

Other

Action the firm took

Stryker Orthopedics issued an Important Stock Recovery letter dated August 2, 2006 The customer was instructed to inspect inventory for the affected product and return it to the firm. The customer was asked to complete and return a Product Accountability Form and contact their Stryker representative for replacement product. Stryker can be contacted about this issue at 201 831-5118.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution: To one location in New Jersey.

Timeline

Recall initiated: 2006-08-02
Posted by FDA: 2010-11-26
Terminated: 2013-11-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74760. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.