Recalling Firm / Manufacturer

Stryker Instruments Div. of Stryker Corporation

Product

Stryker Round Fluted Bur (7.6 mm) Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-75.

Code Information

All lots.

Reason of Recall

Lack of assurance of sterility.

Date Recall Initiated

January 10, 2008

Action

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.

Contact

Al-Jeel Medical & trading Co. ltd.
Riyadh
(01) 4041717

Source of Information

U.S.FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.