Z-1379-2021 Class II Terminated
FDA device recall Z-1379-2021 was initiated by Howmedica Osteonics Corp. on March 5, 2021 and is designated Class II. 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 Cutti… The recall status is terminated (terminated May 10, 2024). Affected quantity: 113 components.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- March 5, 2021
- Termination Date
- May 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 113 components
Product Description
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
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 Pattern
Distribution in US to: CA,, GA, NC, NJ, NV, OK, TX, and to Canada
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