—#85822

Product

Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.

FDA product code: DZI — Drill, Bone, Powered
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K040369
Affected lot / code info: Lots 08311017 and 08336027.

Why it was recalled

The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.

Root cause (FDA determination)

Vendor change control

Action the firm took

Consignees were notified by letter dated 10/5/09 and requested to return the devices to Stryker. The international account was notified by email.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Kalamazoo, Michigan 49001

Distribution

Distribution pattern: USA (California, Georgia, Louisiana, Ohio, Wisconsin) and Brazil.

Timeline

Recall initiated: 2009-10-05
Posted by FDA: 2009-11-16
Terminated: 2009-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85822. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.