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.
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 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
Related recalls
Same manufacturer · Stryker Howmedica Osteonics Corp.
See all →- HighStryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk
FDA (Devices) · 2017-05-31
- SevereStryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
FDA (Devices) · 2017-01-18
- ModerateStryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2016-12-28
- SevereStryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
FDA (Devices) · 2016-11-16
- HighStryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
FDA (Devices) · 2016-10-19
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighStryker Recalls Triathlon MIS Modular Distal Capture Instruments
FDA (Devices) · 2015-11-18
- HighStryker Recalls Triathlon Modular Handle Instruments Due to Fit Issues
FDA (Devices) · 2016-08-17
- SevereStryker Triathlon Tibial Alignment Ankle Clamp Recalled for Cracks
FDA (Devices) · 2013-09-04
- HighStryker Triathlon Tibial Alignment Handle Recalled Due to Weld Defect
FDA (Devices) · 2016-08-17
- HighHowmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang
FDA (Devices) · 2019-10-09
- HighStryker Patella Assembly Instrument Recalled for Component Disassociation Risk
FDA (Devices) · 2016-09-21