Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with… — Class II medical device recall Z-2390-2016
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2016-08-17, distributed nationwide. It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the
| Recall number | Z-2390-2016 |
|---|---|
| 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 | 2016-06-23 |
| Classified | 2016-08-11 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2018-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 47 units |
| Lot numbers | F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15406, F6W15444, F7C15943, F7H16099, F7L16994 |
| Model numbers | I-K3254TA00 |
Product
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
Reason for recall
It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.
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-2390-2016. 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.