Recalls / —

—#162096

Product

STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.

FDA product code

HWC — Screw, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K972233

Affected lot / code info

Model 0234010056, UDI 04546540754561, Lot No. 17278AG2

Why it was recalled

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return.

Recalling firm

Firm

Stryker Corporation

Address

5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern

Distributed domestically to . Distributed internationally to Australia and Mexico.

Timeline

Recall initiated

2017-11-17

Terminated

2024-01-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #162096. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.