Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert — Class II medical device recall Z-2389-2015
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2015-08-26, distributed in OH, RI, SC, WV. Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-
| Recall number | Z-2389-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2015-05-29 |
| Classified | 2015-08-14 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-09-26 |
| Distributed | OH, RI, SC, WV |
| Quantity | 10 units |
| Lot numbers | LEF064 |
| Model numbers | 5530-G-209 |
Product
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.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2389-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.