Spinal navigation guide recalled for naming an incompatible toolcard system
SeaSpine Orthopedics is recalling 310 NorthStar OCT Navigation items because the surgical technique guide incorrectly identified Medtronic Infinity toolcards as compatible.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an incorrect compatibility statement in a technique guide with no stated consequence or reported harm.
Plain-English summary
The Orthofix NorthStar OCT Navigation Surgical Technique Guide and its instruments are being recalled by SeaSpine Orthopedics Corporation. Affected instruments include the Navigation Driver (REF PC2-400012), Navigation Straight Bone Probe (REF PC2-400013) and the 3.5mm and 4.0mm Navigation Drills (REF PC2-400135 and PC2-400140).
The NorthStar OCT Navigation Surgical Technique Guide incorrectly identified both Medtronic's Solera and Medtronic's Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. The instruments are compatible for use with Medtronic's Solera toolcards only.
The record lists 310 units, covering surgical technique guide revisions D0003926A through D0003926D with the REF, UDI-DI and lot details listed in the enforcement record. US distribution covered Connecticut, Texas, Nevada, Colorado, California, Washington, New Jersey, Oregon, Indiana, Michigan, Florida, Pennsylvania, Illinois, Virginia, Alabama, Rhode Island, Missouri, Arizona, Mississippi, South Carolina, Utah, New York, Oklahoma and South Dakota, with distribution outside the United States as well. The FDA has classified the action as Class II.
The record describes an incorrect compatibility statement in the guide and states no consequence or reported injuries. Facilities should follow the firm's instructions.
The recalled product
- Product
- Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill…
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Affected units
- 310
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 (20)
- Surgical Technique Guide revisions: D0003926A
- D0003926B
- D0003926C
- D0003926D. REF/UDI-DI/Lot: PC2-400012/10889981260033/MK81527A
- MK81527ARR
- MK81527ARRR
- MK81574AR
- MK81574AR1
- MK93487A
- MK93488ARR
- MK93489A
- MK93490A
- MK93490ARR
- MK93491AR
- MK93491AR1
- MK943488A
- MK95882A
- MK95882ARR
- ML52083B
- ML53136B
Distribution
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