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.
What this means for you
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.
- Hazard
- sterile-packaging-breach
- contamination-risk
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.
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