Stryker Recalls Triathlon Distal Capture Assembly Due to Weld Disassociation Risk
Stryker Howmedica Osteonics is recalling 2,030 Triathlon Distal Capture Assemblies because a weld may disassociate, potentially causing the trigger mechanism to become loose or disassociated.
What this means for you
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 mechanical failure (weld disassociation) in a surgical implant that could lead to device malfunction during a procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 2,030 units of the Triathlon Distal Capture Assembly (Catalog No: 6541-1-723). This medical device is used by surgeons during primary total knee arthroplasty (TKA) procedures to capture the distal femoral or proximal tibial resection.
The recall was initiated due to a potential for weld disassociation of the cross pin. This defect could lead to a loose or disassociated trigger mechanism on the Distal Capture Assembly. The affected units were distributed worldwide, including in the United States, Puerto Rico, Canada, and numerous international locations such as the UK, France, Germany, and Australia.
The source text does not specify specific actions for consumers or patients, as this is a surgical implant used by healthcare professionals. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 2,030
Distribution
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