—#40932

Product

Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.

FDA product code: DZJ — Driver, Wire, And Bone Drill, Manual
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K040369
Affected lot / code info: All units manufactured June 23, 2005 through July 22, 2005.

Why it was recalled

Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.

Root cause (FDA determination)

Other

Action the firm took

U.S. customer was notified via recall letter dated August 5, 2005 and international affiliates were notified via email. U.S. account was requested to return the product.

Recalling firm

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

Distribution

Distribution pattern: Virginia, Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, Switzerland,

Timeline

Recall initiated: 2005-08-05
Posted by FDA: 2005-08-23
Terminated: 2005-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40932. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.