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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System Trial guide

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  Class 2 Device Recall Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System Trial guide see related information
Date Initiated by Firm March 05, 2021
Date Posted April 09, 2021
Recall Status1 Completed
Recall Number Z-1379-2021
Recall Event ID 87517
510(K)Number K172326  K132624  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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
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 
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Elizabeth Beato
201-831-5000
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by 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.
Quantity in Commerce 113 components
Distribution Distribution in US to: CA,, GA, NC, NJ, NV, OK, TX, and to Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = STRYKER ORTHOPAEDICS
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