Stryker Spine Recalls Radius Rod to Rod Connectors for Missing Clearance
Stryker Spine is recalling 42 units of Radius Rod to Rod Connectors because the device lacks the required FDA 510(k) clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and regulatory compliance issue (missing 510(k) clearance) rather than a physical defect or reported injury, fitting the criteria for a Low severity recall.
Plain-English summary
Stryker Spine is recalling 42 units of the Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530). The device is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients.
The recall was initiated because the device does not have an associated 510(k) submission and subsequent clearance, which is required for Class II medical devices. The recall covers all lots of the product.
The affected units were distributed nationwide, including in 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. Healthcare providers and patients should contact Stryker Spine for further instructions regarding the return or replacement of these devices.
The recalled product
- 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.
- Manufacturer
- Stryker Spine
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog #486614530
- All Lots
Distribution
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