X3 Triathlon CS Insert Recalled for Potential Sterile Packaging Breach
Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert due to potential breaches in the inner and outer sterile packaging. The breaches could compromise device sterility, affecting 132 units in the U.S. and 26 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: FDA Class II recall of a sterile medical device with potential packaging breaches that could result in contamination. This is a risk-of-harm product where injury has not been reported, meeting the Level 3 (High) criterion.
Plain-English summary
Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert No. 3, 10 mm due to potential breaches in the inner and outer sterile packaging. The company identified potential packaging breaches in both the inner blister and outer sterile blister.
A total of 132 units were distributed in the United States nationwide and 26 units were distributed internationally. The affected countries include Australia, Canada, Chile, Colombia, Korea, and Japan. Affected lot numbers include 313JA9, 8711AV, A4462V, XD1AT4, MR77W5, TD5KL3, H97AME, and YW30KL, with products expiring on October 7, 2028.
Patients and healthcare providers should contact Howmedica Osteonics Corp. for further instructions regarding the affected devices.
The recalled product
- Product
- X3 TRIATHLON CS INSERT NO 3 10 MM
- Manufacturer
- Howmedica Osteonics Corp.
- Category
- Medical Device
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 (11)
- Part No. 5531-G-310-E
- GTIN: 07613327390544
- Lot No. 313JA9
- 8711AV
- A4462V
- XD1AT4
- MR77W5
- TD5KL3
- H97AME
- YW30KL
- 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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