Howmedica Recalls Specialty Triathlon TS Trial Cutting Guides Due to Fracture Risk
Howmedica Osteonics Corp. is recalling Specialty Triathlon TS Trial Cutting Guides because the posterior condyle may fracture during transport or surgery.
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 involves a medical device with a structural defect that poses a risk of harm during surgery, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling 113 components of the Specialty Triathlon TS Trial Cutting Guide, sizes 1 through 8, for both left and right knees. These instruments are used in conjunction with the Triathlon Total Knee System, Triathlon PKR System, and Restoris MCK Knee System.
The recall is due to a potential defect where the posterior condyle of the trial cutting guide may fracture at the augment cut slot. This fracture can occur while the instrument is in its packaging during transport or during the impaction of the instrument in surgery.
The affected products were distributed in the United States to California, Georgia, North Carolina, New Jersey, Nevada, Oklahoma, and Texas, as well as to Canada. Healthcare providers and facilities should stop using these specific trial cutting guides and contact Howmedica Osteonics Corp. for instructions on return or replacement.
The recalled product
- Product
- Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set…
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 113
Distribution
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