Recalls / —

—#36544

Product

Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080

FDA product code

HWC — Screw, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K993166

Affected lot / code info

Part Number: 234-010-078, Lot # 32101;  Part Number: 234-010-080, Lot # 32103

Why it was recalled

The label on the outside of the shipping box has an incorrect description of the screw diameter.

Root cause (FDA determination)

Other

Action the firm took

Consignees have been alerted by phone calls on 12/16/2004. Formal advisory notice was sent out on 12/27/2004. All international consignees have also been alerted.

Recalling firm

Firm

Stryker Endoscopy

Address

5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern

6 consignees (locations to be determined) received 15 units. the remaining 147 units were distributed to international divisions.

Timeline

Recall initiated

2004-12-27

Posted by FDA

2005-01-15

Terminated

2005-03-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #36544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.