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
Check against the official notice below — it lists the full affected range.
Howmedica Osteonics Corp. has recalled Specialty Triathlon TS Trial Cutting Guides (sizes 1 through 8, left and right) used in knee replacement surgery procedures. The posterior condyle of these surgical instruments can fracture at the augment cut slot, either during packaging and transport or during surgical use when the instrument is being inserted.
A total of 113 components were distributed across the United States (California, Georgia, North Carolina, New Jersey, Nevada, Oklahoma, and Texas) and Canada. The recall covers all lot numbers associated with the affected GTINs. The source document does not specify a remedy or further actions consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Distribution in US to: CA,, GA, NC, NJ, NV, OK, TX, and to Canada Quantity: 113 components Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.