Triathlon TS Plus tibial inserts recalled for potential packaging breaches
Howmedica Osteonics Corp. is recalling Triathlon TS Plus tibial inserts due to potential breaches in sterile packaging that could compromise product sterility. Affected units were distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a sterile medical implant with potential packaging breaches. While the hazard poses risk to patients, no illnesses or injuries have been reported, placing this in the High category per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM tibial inserts (knee implant components) due to potential packaging breaches that could compromise sterility.
The recalled units were identified due to potential breaches in both the inner blister and outer sterile blister packaging. Such breaches may allow contamination of the sterile implant. Eighteen units of the affected lot were distributed within the United States and five units were distributed internationally to Australia, Canada, Chile, Colombia, Korea, and Japan. The affected lot number is E97TH6, with an expiration date of October 7, 2028, and product code 5537-G-411-E.
Healthcare providers and patients should contact Howmedica Osteonics Corp. for detailed information about the recall and available options.
The recalled product
- Product
- NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
- Manufacturer
- Howmedica Osteonics Corp.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Part No. 5537-G-411-E
- GTIN: 07613327287691
- Lot No. E97TH6
- Expiration Date: 10/07/2028.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- ModerateHowmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls Triathlon Universal Baseplate Finishing Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Triathlon Instrument Trays Recalled for Sterilization Dry Time Issue
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls TS Femoral Prep Trays Due to Sterilization Instructions
FDA (Devices) · 2026-10-21
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
Same hazard · sterile packaging breach
See all →- HighCenturion Sterile Weitlaner Retractor recalled for sterile packaging puncture risk
FDA (Devices) · 2025-05-21
- HighBlade Puncture Risk in Femoral Artery Sterile Procedural Trays
FDA (Devices) · 2023-02-15
- HighProcedural trays recalled for potential sterile packaging breach
FDA (Devices) · 2023-02-08
- HighMEDLINE procedural trays recalled for potential sterile packaging breach
FDA (Devices) · 2023-02-08
- HighMedline CISION Sterile Surgical Blades Recalled for Sterile Packaging Breach Risk
FDA (Devices) · 2023-01-18
Similar recalls
- ModerateStryker Recalls Mislabelled Triathlon Tibial Inserts for Knee Replacement
FDA (Devices) · 2015-08-19
- HighKnee Replacement Insert Mislabeled; Contents May Not Match Catalog Number
FDA (Devices) · 2023-06-07
- HighKnee replacement implant bearing inserts mislabeled with wrong catalog numbers
FDA (Devices) · 2023-06-07
- ModerateStryker Triathlon X3 Tibial Bearing Insert Recall Due to Labeling Error
FDA (Devices) · 2015-08-26
- ModerateStryker Triathlon Femoral Component Recalled for Sterile Barrier Seal Issues
FDA (Devices) · 2015-05-27
- HighTriathlon orthopaedic implant baseplate recalled for assembly defect
FDA (Devices) · 2021-08-25