CLASS II Device recall · Reported 26 Aug 2015 · FDA Enforcement Report
Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR recalled
Stryker Howmedica Osteonics is recalling Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR, distributed in Ohio, Rhode Island, South Carolina, West Virginia. The recall was initiated on 29 May 2015 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-2389-2015
- FDA event ID
- 71678
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 May 2015
- FDA classified
- 14 Aug 2015
- Reported
- 26 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 29 May 2015 | Recall initiated by company | |
| 14 Aug 2015 | Classified by FDA | +77 days |
| 26 Aug 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).
Product as listed by the FDA
Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
Where it was distributed
OH, SC, RI, WV
Questions about this recall
Is Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR recalled?
Yes. Stryker Howmedica Osteonics recalled Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR on 29 May 2015. The recall is Class II and its status is Terminated. Recall number Z-2389-2015.
Why was it recalled?
Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).
Which lots are affected?
Catalog number 5530-G-209 Lot Code LEF064
Where was it sold?
OH, SC, RI, WV
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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