Device Recall Triathlon

Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right).   Lot Codes: AP5W52 and AP7H19.

Orthopedic Devices

1

No

1 Branch (NJ) with one consignee (DE).

Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE

Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG

Orthopedic Devices

2

Yes

Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.

Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package || Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA || Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 || Meyzieu, Cedex, France || This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone

Product numbers: 5537-G-109, 5537-G-111, 5537-G-113, 5537-G-116, 5537-G-119, 5537-G-122, 5537-G-125, 5537-G-128, 5537-G-131, 5537-G-209, 5537-G-211, 5537-G-213, 5537-G-216, 5537-G-219, 5537-G-222, 5537-G-225, 5537-G-228,  5537-G-231, 5537-G-309, 5537-G-311, 5537-G-313, 5537-G-316, 5537-G-319, 5537-G-322, 5537-G-325, 5537-G-328, 5537-G-331, 5537-G-409, 5537-G-411, 5537-G-413, 5537-G-416, 5537-G-419, 5537-G-422, 5537-G-425, 5537-G-428, 5537-G-431, 5537-G-509, 5537-G-511, 5537-G-513, 5537-G-516, 5537-G-519, 5537-G-522, 5537-G-525, 5537-G-528, 5537-G-531, 5537-G-609, 5537-G-611, 5537-G-613, 5537-G-616, 5537-G-619, 5537-G-622, 5537-G-625, 5537-G-628, 5537-G-631, 5537-G-709, 5537-G-711, 5537-G-713, 5537-G-716, 5537-G-719, 5537-G-722, 5537-G-725, 5537-G-728, 5537-G-731, 5537-G-809, 5537-G-811, 5537-G-813, 5537-G-816, 5537-G-819, 5537-G-822, 5537-G-825, 5537-G-828, 5537-G-831.  All lot codes

Orthopedic Devices

2

Yes

Product distributed to 5 hospitals in GA, OH, MN, TX.

Triathlon X3 || Total Stabilizer + Tibial Insert || For use with Triathlon Universal Baseplates, knee prosthesis. || #5 13mm || Stryker Orthopaedics

Catalog Number 6541-4-805 Lot Code NYC08

Orthopedic Devices

1

No

Worldwide Distribution

Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Stryker Howmedica Osteonics Corp, Mahwah, NJ 07430

Lot codeL WFLD

Orthopedic Devices

1

No

Nationwide Distribution --- including states of CT, NJ, PA, VA, NC, GA, FL, AL, MI, MN, IL, TX and AZ.

Triathlon TS Femoral Trial; || Size 1 Left || Non-Sterile || Catalog number 5512-T-101 || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 || Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.