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.
Reported: November 18, 2015 Initiated: September 25, 2015 #Z-0270-2016
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.
Details
- Recalling Firm
- Stryker Spine
- Units Affected
- 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.
- Location
- Allendale, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Spine. Units affected: 42 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2015. Severity: Moderate. Recall number: Z-0270-2016.
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