U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
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.
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.
제품 설명
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.