Z-0270-2016 Class II Terminated
FDA device recall Z-0270-2016 was initiated by Stryker Spine on September 25, 2015 and is designated Class II. 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 … The recall status is terminated (terminated July 26, 2016). Affected quantity: 42 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 18, 2015
- Initiation Date
- September 25, 2015
- Termination Date
- July 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 units
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.
Distribution Pattern
Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NM, NY, OH, OK, OR, PA, TN, TX, UT, WA and WI.
Code Information
Catalog #486614530, All Lots