Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is des

FDA device recall Z-0610-2013 · posted 2012-12-22 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.

Action taken

The firm, Stryker Orthopaedics, sent an "URGENT MEDICAL DEVICE REMOVAL" letter & Acknowledgement form dated August 7, 2012 via FedEx Return Receipt to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to inform their users of this Medical Device Removal and pass this notice to all those individuals who need to be aware within their organization; return all affected products available at their location to: Stryker Osteosynthesis, 325 Corporate Drive, Mahwah, NJ 07430 REF: PFA#2012-124 or contact Stryker customer service; complete and sign the enclosed Product Recall Acknowledgement Form and Fax to 1-855-251-3635 or email to Recall Coordinator at janice.pevide@stryker.com and keep a copy of their records. If you have any questions, contact the Manager, Regulatory Compliance, at 1-201-972-2100 or email: colleen.omeara@stryker.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LXH

Quantity affected

100 units (73 units US; 27 units OUS)

Distribution

Worldwide distribution: USA (nationwide) including states of: AL, CO, CT, IL, IN, MO, MS, NC, NJ, NY, OR,and TX; and countries of: Australia, Canada, France, Spain and United Kingdom.

Date initiated

2012-08-06

Date posted

2012-12-22

Date terminated

2013-09-11

Location

Mahwah, NJ