Recall Z-2487-2012— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-2487-2012
Creator: U.S. Food and Drug Administration
Published: 2012-04-02

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2012-04-02, terminated 2013-06-13. It names 3 FDA 510(k) clearances: K040734, K022549, K013106. Product: Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body trials is an assembly of the Body and 8 mm Hex Locking Bolt. The trial stem is attached to the trial Cone body via the distal thread of the Locking bolt.. Reason: Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2012-04-02
Terminated: 2013-06-13
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

3 on FDA's record

K040734 — MODIFICATION TO RESTORATION MODULAR SYSTEMHowmedica Osteonics Corp.·cleared 2004-08-25
K022549 — RESTORATION MODULAR SYSTEMHowmedica Osteonics Corp.·cleared 2002-09-23
K013106 — 2 PIECE MODULAR HIP STEMHowmedica Osteonics Corp.·cleared 2002-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body trials is an assembly of the Body and 8 mm Hex Locking Bolt. The trial stem is attached to the trial Cone body via the distal thread of the Locking bolt.

Reason for recall

Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section.

Data sourced from openFDA. This site is unofficial and independent of the FDA.