FDA Device recall Z-0270-2016
Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530 by Stryker Spine, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0270-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-25 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Spine |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog #486614530, All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0270-2016%22
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