CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
X3 Triathlon Cs Insert No recalled by Howmedica Osteonics
Howmedica Osteonics is recalling X3 Triathlon Cs Insert No 7, distributed nationwide in the US. The recall was initiated on 6 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1262-2024
- FDA event ID
- 94026
- Recalling firm
- Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Feb 2024
- FDA classified
- 6 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 6 Feb 2024 | Recall initiated by company | |
| 6 Mar 2024 | Classified by FDA | +29 days |
| 13 Mar 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential packaging breaches of inner blister and outer sterile blister.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
X3 TRIATHLON CS INSERT NO 7 9 MM
Where it was distributed
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
Questions about this recall
Why was it recalled?
Potential packaging breaches of inner blister and outer sterile blister.
Which lots are affected?
Part No. 5531-G-709-E; GTIN: 07613327337464; Lot No. KA1Y71; Expiration Date: 11/08/2028.
Where was it sold?
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 94026This product is part of a recall event; the main page for the event is No 4 Triathlon Ts Plus Tib Ins X3 Poly recalled by Howmedica Osteonics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | No 4 Triathlon Ts Plus Tib Ins X3 Poly recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | Nationwide | |
| CLASS II | X3 Triathlon Cs Insert No recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | Nationwide | |
| CLASS II | X3 Triathlon Cs Insert No recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | Nationwide | |
| CLASS II | No 3 Triathlon Ts Plus Tib Ins X3 Poly recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | Nationwide | |
| CLASS II | X3 Triathlon Cs Insert No recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | Nationwide | |
| CLASS II | No 4 Triathlon Ts Plus Tib Ins X3 Poly recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | Nationwide | |
| CLASS II | No 4 Triathlon Ts Plus Tib Ins X3 Poly recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | Nationwide |
More recalls from Howmedica Osteonics
All 232| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tri Ts Baseplate Size recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | Nationwide |
| Device | CLASS II | Tri Ts Baseplate Size recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | Nationwide |
| Device | CLASS II | MICS3 Angled Sagittal Saw Attachment recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | The Stryker CranialMask Tracker is a single-use device recalled | Howmedica Osteonics | Device Malfunction | Nationwide |
| Device | CLASS II | Exeter V40 Stem No recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | NJ |
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| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |