Recalls / —

—#86983

Product

Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-120.

FDA product code

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

Device class

Class 2

Medical specialty

Neurology

510(k) numbers

K032303, K040300

Affected lot / code info

All lots distributed 1/30/06 through 3/4/09. Lots 06004017, 06034017, 06075017, 06086017, 06206017, 07002017, 07039017, 07067017, 07121017, 07219017, 07279017, 07320017, 07346017, 08007017, 08030017, 08044017, 08081017, 08205017, 08275017 and 09043017.

Why it was recalled

The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.

Root cause (FDA determination)

Device Design

Action the firm took

Consignees were sent a letter dated 7/10/09 instructing them to locate and return product on hand for replacement. Surgeons who use the product were notified via a separate, untitled letter, dated July 13, 2009. A speed warning will be added to the product labels. Questions are directed to the firm at: 1-800-800-4236 ext. 3808.

Recalling firm

Firm

Stryker Instruments Div. of Stryker Corporation

Address

4100 E. Milham Ave., Kalamazoo, Michigan 49001

Distribution

Distribution pattern

Nationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan.

Timeline

Recall initiated

2009-07-06

Posted by FDA

2010-01-11

Terminated

2010-10-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #86983. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.