Recall Z-2759-2019— Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2019-08-19, terminated 2020-05-06. It names 2 FDA 510(k) clearances: K190991, K141056. Product: TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon 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) Catalog # 5542-A-201 - Product Usage:. Reason: Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component.
- Recalling firm
- Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-19
- Terminated
- 2020-05-06
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K190991 — Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
- K141056 — TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon 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) Catalog # 5542-A-201 - Product Usage:
Reason for recall
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Data sourced from openFDA. This site is unofficial and independent of the FDA.