Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-0270-2016

U.S. FDA — Device Enforcement · United States · 2015-09-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0270-2016
Date of alert
2015-09-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Spine
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
486614530
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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