Recall Z-0270-2016 ยท NKB Thoracolumbosacral Pedicle Screw System
Stryker Spine
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.
| Date | Sep 25, 2015 |
| Status | Terminated |
| 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. |
| Root cause | No Marketing Application |
| Action | 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. |
| Quantity | 42 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.