Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang
Howmedica Osteonics Corp. is recalling 171 units of Triathlon Femoral Distal Augments due to a device overhang issue that protrudes beyond the mating femoral component.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device used in surgery, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Howmedica Osteonics Corp. is recalling 171 units of the TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT (Catalog # 5541-A-202). These medical devices 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.
The recall is due to a device overhang issue that protrudes beyond the medial periphery of the mating femoral component. The affected units are all lots with an expiration date on or before 31 June 2024. The recall covers worldwide distribution, including the United States and numerous international countries.
Healthcare providers and patients should contact Howmedica Osteonics Corp. for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-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…
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 171
Distribution
Part of a larger recall action
This product is one of 4 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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