Stryker Radius 5 — Class II medical device recall Z-0270-2016
Terminated recall by Stryker Spine, reported 2015-11-18, distributed nationwide. Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not
| Recall number | Z-0270-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2015-09-25 |
| Classified | 2015-11-12 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 42 units |
| Model numbers | 486614530, 48664530 |
Product
Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients.
Reason for recall
Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not have an associated 510(k) submisstion and subsequent clearance, which is required as this is a class 2 device.
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-0270-2016. 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.