TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triat...
FDA Device Recall #Z-2760-2019 — Class II — August 19, 2019
Recall Summary
| Recall Number | Z-2760-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 19, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Howmedica Osteonics Corp. |
| Location | Mahwah, NJ |
| Product Type | Devices |
| Quantity | 159 units |
Product Description
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
Reason for Recall
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Distribution Pattern
Worldwide distribution - US Nationwide distribution including the states of AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Honk Kong, India, Ireland, Iran, Italy, Israel, Japan, Kazakhstan, Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and UK.
Lot / Code Information
All lots with an expiration date on or before 31 June 2024. Lot# A3G9I A3L3E A494U A737R A7O3V A9Z9I AB34V AEU3A AEV4T AGT3G AGU9H AH73U AHE9A ALS7R AOG7L ARD3S ASS9S ASU7H ATY7Z AXZ3G AY37S BAS4A BBX7R BDV9H BEL3L BEZ3G BG34H BGL3Y BLZ4V BO49D BOA3B BOX9G BRG9O BRV7A BRY9V BSR7E BSS4B BTB3H DGKJ DGSH DIXP DKAX FYPO FYRV GFMT GJLZ GJNG GLDO GZJM GZNW GZSO GZTX GZXN GZXP HUTX HWPK HXYV IBPA IBPG IDXU IKKL IKUD IMUI ISHW IXVN IYSN IZUI JBSB JBXN JHAF JHGV JJFK JORA JUWH JZWG KDER KDZP KEOH KFXJ KGSW KJEK KJHN KKPN KLXZ KSGD KSPF KTLH KUAI KUKW KYBZ LBAM LBFD MBZM MDBV MERR MFSR MIRW MMLL SZSR TROU TRVH UEYI UHER UZIY VETP VJMC VJOS VUWS VVCY VVDW WHDY WISW WIWZ WRTS WRXX WTDT WVVP WVZC WXBU WXBV WXBW WXPH WXPI WXPJ XBEH XBEI XDBP XDBR XIJA XKIW XKIX XNAC XNBF XNCN XRBV XRBW XTAS XTAT XVHZ XVMM XVMN XVNA XXIW XXIX XYHM XYHN YBDF YBDG YCEY YCEZ YCZV YCZW YFCI YFCJ YGJM YGJN YHHU YHPT YHPU
Other Recalls from Howmedica Osteonics Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1572-2026 | Class II | MICS3 Angled Sagittal Saw Attachment; Part Num... | Feb 2, 2026 |
| Z-0963-2026 | Class II | The Stryker CranialMask Tracker is a single-use... | Nov 12, 2025 |
| Z-2640-2025 | Class II | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Num... | Aug 28, 2025 |
| Z-0023-2025 | Class II | Triathlon Universal TS Baseplate Size 2 - A sin... | Sep 4, 2024 |
| Z-0044-2025 | Class II | MAKO Integrated Cutting System (MICS) HANDPIECE... | Aug 7, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.