FDAFDA · Food and drugs·Recall number Z-0270-2016
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.
Published November 18, 2015 · Recall initiated: September 25, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Spine
- Distributor
- 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
- Catalog #486614530, All Lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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