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Terminated

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.

FDA Recall Z-0270-2016 · Posted None

Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeNKB
Date Initiated2015-09-25
Date Terminated2016-07-26
Product Quantity42 units

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.

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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