CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report
Stryker Radius 5.5 to 3.5 Rod to Red Connector recalled by Stryker Spine
Stryker Spine is recalling Stryker Radius 5.5 to 3.5 Rod to Red Connector, distributed nationwide in the US. The recall was initiated on 25 Sep 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0270-2016
- FDA event ID
- 72413
- Recalling firm
- Stryker Spine, Allendale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Sep 2015
- FDA classified
- 12 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 25 Sep 2015 | Recall initiated by company | |
| 12 Nov 2015 | Classified by FDA | +48 days |
| 18 Nov 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth Carolina
Questions about this recall
Why was it 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 lots are affected?
Catalog #486614530, All Lots
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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