—#67268

Product

Stryker 3.0mm x 3.8mm Precision Neuro Drill Extended Long for use with Long "AM" attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5230-107-530S1.

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 #67268. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.