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.
- Company
- Stryker Spine
- Recall Initiated
- September 25, 2015
- Terminated
- July 26, 2016
- Recall Number
- Z-0270-2016
- Quantity
- 42 units
- Firm Location
- Allendale, NJ
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
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.
Lot / Code Info
Catalog #486614530, All Lots
Root Cause
No Marketing Application
Action Taken
Stryker Spine initiated this recall by sending an "Urgent Product Removal Letter and Product Accountability Form dated September 25, 2015 to the Branch Manager, Agency Manager, Quality Contact via FedEx priority overnight.