—#162100

Product

ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

FDA product code: KDD — Kit, Surgical Instrument, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Model 0234020280, UDI 07613154643264, Lot No. 17299AG2

Why it was recalled

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.

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 #162100. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.