Stryker Corporation

Lot Numbers Affected: 13604

Orthopedic Devices

1

No

GA, UT, MD, NJ, MT

Stryker FlowPort II Adapter: Model number: 00CAT00778 || The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.

a. Model 0250070500, Product Code GCJ, UDI 07613327061390, Lot No. 17275FG2, 17276FG2, 17277FG2, 17278FG2, 17279FG2, 17280FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17290FG2, 17291FG2, 17292FG2, 17293FG2, 17294FG2, 17297FG2, 17299FG2, 17301FG2); 0250070505, 0250070520;  b. Model 0250070505, Product Code GCX, UDI 07613327061406, Lot No. 17294FG2;  c. Model 0250070520, Product Code GCX, UDI 07613327061369, Lot No. 17282FG2, 17283FG2, 17286FG2, 17289FG2, 17290FG2, 17292FG2, 17293FG2, 17294FG2, 17296FG2, 17297FG2, 17298FG2, 17299FG2, 17300FG2, 17301FG2, 17302FG2

General and Plastic Surgery Devices

2

No

Distributed domestically to . Distributed internationally to Australia and Mexico.

StrykeFlow 2 System, labeled sterile. Includes the following: || a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); || b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); || c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) || STRYKER LAPAROSCOPIC SUCTION IRRIGATOR

Serial/Lot Number(s) Affected: 4600: 15J456; 4601: 16A463, 16G470, 17F510; 4607: 16A461, 16D465, 16E467, 16F468, 17E506, 17E507; 4612: 16A458, 16A459, 17D489, 17E503, 17E504

Orthopedic Devices

2

Yes

Netherlands

CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant || Product Usage: || The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.

a. Model 0250070600, UDI 07613327061499, Lot No. 17284FG2, 17291FG2, 17300FG2;  b. Model 0250070620, UDI 07613327061659, Lot No. 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, 17299FG2;

General Hospital and Personal Use Devices

2

No

Distributed domestically to . Distributed internationally to Australia and Mexico.

STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: || a. Stryker AHTO Tube Set Packaging (Model 0250070600); || b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);

Model 0234010056, UDI 04546540754561, Lot No. 17278AG2

Orthopedic Devices

2

Yes

Distributed domestically to . Distributed internationally to Australia and Mexico.

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