Stryker Spine: Medical Device Recall in 2015 - (Recall #: Z-0270-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 25, 2015

Date Posted: November 18, 2015

Recall Number: Z-0270-2016

Event ID: 72413

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.

Status: Terminated

Product Quantity: 42 units

Code Information:

Catalog #486614530, All Lots

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.

Voluntary or Mandated:

Voluntary: Firm initiated