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Recall Observatory FDA recall evidence

Device 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 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

Z-1379-2021

March 05, 2021

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 87517
Status
Terminated
Classification
Class II
Quantity
113 components
Official record key
device-enforcement:Z-1379-2021

Official wording

Reason: 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.

Code information: All Lot numbers for each GTIN: GTIN: 07613327327595 GTIN: 07613327327533 GTIN: 07613327327748 GTIN: 07613327329209 GTIN: 07613327329193 GTIN: 07613327329100 GTIN: 07613327329087 GTIN: 07613327329063 GTIN: 07613327328899 GTIN: 07613327328868 GTIN: 07613327328707 GTIN: 07613327328691 GTIN: 07613327328592 GTIN: 07613327328530 GTIN: 07613327328639 GTIN: 07613327328424 GTIN: 07613327328288

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.