X3 Triathlon inserts recalled for potential sterile packaging breaches
Howmedica Osteonics Corp. is recalling X3 Triathlon inserts due to potential breaches in sterile packaging. The breach could compromise device sterility and allow contamination if the affected units are used.
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: FDA Class II device recall involving potential sterility-compromising packaging defects. No illnesses or injuries reported, limiting severity to 3 per rubric criteria for risk-of-harm medical devices without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert No. 6 11 MM (Lot No. HL7228), distributed in the United States and internationally to Australia, Canada, Chile, Colombia, Korea, and Japan. A total of 24 units in the U.S. are affected by this recall.
The recall was initiated due to potential breaches in the inner blister and outer sterile blister packaging of the device. A breach in the sterile packaging could allow contamination of the device during storage, transportation, or handling prior to use.
Patients and healthcare providers should contact Howmedica Osteonics Corp. or the FDA with questions about affected devices. Healthcare facilities in possession of affected units should quarantine them pending further instructions from the manufacturer.
The recalled product
- Product
- X3 TRIATHLON CS INSERT NO 6 11 MM
- Manufacturer
- Howmedica Osteonics Corp.
- Category
- Medical Device
- Affected units
- 24
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. 5531-G-611-E
- GTIN: 07613327337341
- Lot No. HL7228
- Expiration Date: 11/08/2028.
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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