Recalls / —

—#41424

Product

Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138

FDA product code

HWC — Screw, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K021351

Affected lot / code info

04/05-PH134

Why it was recalled

The medical device is misbranded in that the package is labeled as Biosteon Interference Screw in fact contains Biosteon Cross Pin. This mislabeling could disrupt surgery preparation resulting in surgery delay.

Root cause (FDA determination)

Other

Action the firm took

On 8/23/05, all consignees were notified via telephone, written letter and also via sales representative, informing them of the affected product and providing instructions on the recall.

Recalling firm

Firm

Stryker Endoscopy

Address

5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern

The product was distributed nationally to 8 consignees and internationally to 12 consignees via distributors and directly to physicians and/or medical facilities. Foreign countries include, Canada, Poland and Italy. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, physicians and medical facilities who received the recalled product.

Timeline

Recall initiated

2005-08-23

Posted by FDA

2005-11-18

Terminated

2005-11-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #41424. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.