Orthopedic knee implant recalled for potential sterile packaging breaches
Howmedica Osteonics Corp. is recalling the NO 3 Triathlon TS Plus Tibial Insert due to potential breaches in the sterile packaging. The breaches could compromise product sterility and safety.
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: FDA Class II recall of a sterile medical device with packaging breaches that could compromise sterility. No reported illnesses or injuries. Meets rubric criterion for High (3): risk-of-harm product without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling the NO 3 Triathlon TS Plus Tibial Insert due to potential packaging breaches of the inner blister and outer sterile blister. The device is an orthopedic implant used in knee procedures.
The recall affects approximately 39 units distributed across the United States and 10 units distributed internationally to Australia, Canada, Chile, Colombia, Korea, and Japan. The recalled product has the following identifiers: Part Number 5537-G-311-E, GTIN 07613327288063, Lot Numbers EP81Y7 and YL5VKA, with an expiration date of 10/07/2028.
A breached sterile barrier on a medical implant could potentially allow contamination. Patients or healthcare providers who have received this device should consult with their healthcare provider for further guidance.
The recalled product
- Product
- NO 3 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 (5)
- Part No. 5537-G-311-E
- GTIN: 07613327288063
- Lot No. EP81Y7
- YL5VKA
- 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.
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