Z-0270-2016Class II

Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during...

Name: Z-0270-2016 Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during...
Creator: Stryker Spine
Published: 2015-09-25
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-09-25 / Terminated

FDA source

Stryker Spine began a recall of 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... on 2015-09-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0270-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-25
Posted: 2015-11-12
Terminated: 2016-07-26
Recalling firm: Howmedica Osteonics Corp
Product: 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 code: NKB Thoracolumbosacral Pedicle Screw System
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.
FDA root cause: No Marketing Application
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.
Quantity in commerce: 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.
Product codes and lots: Catalog #486614530, All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0270-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0270-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-12

Product code NKB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)