Trial Cutting Guide for Triathlon Total Knee System, Tria... (Howmedica Osteonics Corp.) – laceration hazard (2021)
This product may cause serious physical injury.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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-K383
Brand
Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Howmedica Osteonics Corp. is recalling Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, due to 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 a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, GA, IN, NV, NJ, NC, OK, TX
Page updated: Jan 10, 2026