Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill

FDA device recall Z-2487-2012 · posted 2012-09-28 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

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.

Action taken

Stryker Orthopaedics sent a Urgent Product Field Action - Product Inspection Branch Acknowledgement Form on April 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. All inspections must be completed immediately as per the provided Product Correction Bulletin. Please document the results of your inspection on the Tracking Log, indicating conforming devices as "Not Affected" and non-conforming devices as "To be returned." If the devices listed on your tracking log have previously been returned or are otherwise not on hand, indicate the appropriate disposition following our usual process. Please assist us in meeting our regulatory obligation by faxing back the attached Product Acknowledgment Form and Tracking Log within 10 business days to 855-251-3635. Any further questions please call 201-831-5523.

Root cause

Device Design

Status

Terminated

Product code

LZO

Quantity affected

10, 983 units

Distribution

Nationwide distribution

Date initiated

2012-04-02

Date posted

2012-09-28

Date terminated

2013-06-13

Location

Mahwah, NJ

Related 510(k) clearances