Recalls / —

—#67265

Product

Stryker 3.1mm x 19.1mm Straight Router, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-70-31.

FDA product code

HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered)

Device class

Class 2

Medical specialty

Neurology

510(k) numbers

K032303

Affected lot / code info

All lots.

Why it was recalled

Lack of assurance of sterility.

Root cause (FDA determination)

Package design/selection

Action the firm took

Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.

Recalling firm

Firm

Stryker Instruments Div. of Stryker Corporation

Address

4100 E. Milham Ave., Portage, Michigan 49002-9704

Distribution

Distribution pattern

Worldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates.

Timeline

Recall initiated

2008-01-10

Posted by FDA

2008-04-22

Terminated

2009-12-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #67265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.