TRIATHLON FEMORAL DISTAL AUGMENT 10MM — Class II medical device recall Z-2757-2019
Terminated recall by Howmedica Osteonics Corp., reported 2019-10-09, distributed nationwide. Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
| Recall number | Z-2757-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2019-08-19 |
| Classified | 2019-09-27 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2020-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, DE, DK, ES, FI, FR, GB, IE, IL, IN, IR, IT, JP, KR, KW, MX, MY, NL, NO, NZ, PL, PT, RO, RU, SA, SE, SG, TH, TR, TW, ZA |
| Quantity | 167 units |
| Lot numbers | A3A4G, A3O4G, A7E4A, A7S7Y |
| Model numbers | 5541-A-201 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2757-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.