TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triath...
FDA Device Recall #Z-2757-2019 — Class II — August 19, 2019
Recall Summary
| Recall Number | Z-2757-2019 |
| 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 | 167 units |
Product Description
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - 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 # A3A4G A3O4G A7E4A A7S7Y AABP AABR AAS7L ABI3L ABY7A AE44H AEB7H AER7Y AGS7H AHS4D AIA7Y AII4Z ALR4L AOU3R ARG9T ASZ3O ATG4X ATU7D AVG7Z AVO9H AYG9Y AYX3Y BAE3E BAU3L BE93T BEB4L BGU4G BHL9O BIE7H BL74I BLL9A BRE9E BRO7U BRY4Y BS97E BSH7H BSO3G BTE4D DNVL DRSG DVXW DZKF FUXX FVAH GARO GAWP GBTP GJZD GKAJ GKDW GLAN GLBU GLHI GLHY HHRP HHVI HXGO HXML HXUV HYHY HZBN HZKZ HZNH IBSA IBZA IDZV IKGT IKKM ILHJ INIM INLE ITMY IXNB IYRK JBOV JDJY JEUD JIOX JIYT JJZE JKFX JKYF JLIF JOJF JWEF JWVL JYWU JZYF KEXO KMFK KMGH KMIS KOHJ KPNX KRPW KSNI KUZR KVYS MDZU MLWL MNKY MOHT MPNI MROZ S3HR SSVR TGOB U3BV ULIO USUR UZYY V4ZD VADL VGLG VHWH VJHI VJYL VPSZ VRDA VTYL VWRZ VZVT WDVE WIRA WISA WOTL WOUL WRUR WRUS WVZO WWEP WXTS WXTT WXTU WZP3 XEMZ XENA XHZU XKWY XKWZ XLRY XLRZ XSFN XSFP XSZE XSZF XVJA XVKZ XWVJ XWWZ XYGU XYGV YBJJ YBJK YCZR YCZS YFXP YFXR YGDI YGDZ YHDM YHDN
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.