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Terminated

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 I-K3834CG1L Specialty Triathlon TS Trial Cutting Guide Size 1 Left I-K3834CG1R Specialty Triathlon TS Trial Cutting Guide Size 1 Right I-K3834CG2L Specialty Triathlon TS Trial Cutting Guide Size 2 Left I-K3834CG2R Specialty Triathlon TS Trial Cutting Guide Size 2 Right I-K3834CG3L Specialty Triathlon TS Trial Cutting Guide Size 3 Left I-K3834CG3R Specialty Triathlon TS Trial Cutting Guide Size 3 Right I-K3834CG4L Specialty Triathlon TS Trial Cutting Guide Size 4 Left I-K3834CG4R Specialty Triathlon TS Trial Cutting Guide Size 4 Right I-K3834CG5L Specialty Triathlon TS Trial Cutting Guide Size 5 Left I-K3834CG5R Specialty Triathlon TS Trial Cutting Guide Size 5 Right I-K3834CG6L Specialty Triathlon TS Trial Cutting Guide Size 6 Left I-K3834CG6R Specialty Triathlon TS Trial Cutting Guide Size 6 Right I-K3834CG7L Specialty Triathlon TS Trial Cutting Guide Size 7 Left I-K3834CG7R Specialty Triathlon TS Trial Cutting Guide Size 7 Right I-K3834CG8L Specialty Triathlon TS Trial Cutting Guide Size 8 Left I-K3834CG8R Specialty Triathlon TS Trial Cutting Guide Size 8 Right

FDA Recall Z-1379-2021 · Posted 2021-04-09

Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2021-03-05
Date Terminated2024-05-10
Product Quantity113 components

Reason for Recall

The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.

Firm Action

On 3/4/2021, Stryker issued an Urgent Medical Device Recall notice to customers via letter due to Stryker has initiated a voluntary, catalog number specific recall for the Specialty Triathlon TS Trial Cutting Guide, sizes 1 through 8, (Left and Right). The intent of this letter is to list hazards and harms potentially associated with the above referenced product and to list any risk mitigation factors. For questions or concerns after reviewing this letter, please contact Customer Service at (201) 831-5000.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution in US to: CA,, GA, NC, NJ, NV, OK, TX, and to Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017-10-30K132624TRIATHLON TRITANIUM METAL-BACKED PATELLAStryker Orthopaedics · 2013-11-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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