Recall Z-0270-2016— Stryker Spine
Class II · Terminated
Class II FDA medical device recall by Stryker Spine, initiated 2015-09-25, terminated 2016-07-26. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Stryker Spine
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-25
- Terminated
- 2016-07-26
- Firm location
- Allendale, NJ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.