Recalls / —

—#67224

Product

Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138

FDA product code

HRX — Arthroscope

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K951267

Affected lot / code info

Lot Numbers: 55-059169, 55-059965, 45165M-3, 44252M-1, and 44660M-1.

Why it was recalled

Slider Lock Failure - The ACL Workstation slider, a component of the ACL workstation, does not consistently lock into the ACL Workstation Base.

Root cause (FDA determination)

Component design/selection

Action the firm took

On January 9, 2008, sales representatives were notified via telephone. All consignees were mailed an Urgent: Device Removal notice, dated January 10, 2008. The firm requested that any affected inventory in stock be quarantined and returned to Stryker Endoscopy for destruction. A response form with return postage was included with notification mailed to all consignees.

Recalling firm

Firm

Stryker Endoscopy

Address

5900 Optical Ct, San Jose, California 95138

Distribution

Distribution pattern

Worldwide Distribution - including USA states of South Carolina, Oregon, Michigan, Nebraska, Maryland, California, New Mexico, Ohio, Texas, West Virginia, Massachusetts, and Florida and countries of Canada, Mexico, Hong Kong, Argentina, Brazil, France, Germany, Greece, Spain, India, Italy, Columbia, Switzerland, Poland, Sweden, Australia, and Netherlands.

Timeline

Recall initiated

2007-12-07

Posted by FDA

2008-04-02

Terminated

2008-12-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #67224. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.