Graft Tube shaft may detach from funnel head during surgical use
Spineology is recalling 190 Graft Tubes because the shaft may detach from the funnel head when not used as instructed, potentially compromising spinal surgical procedures.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a potential structural defect (shaft detachment) in a surgical instrument. No injuries or illnesses have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
The FDA is recalling Spineology's Graft Tube, a surgical instrument used during spinal procedures to deploy flowable graft material. The device is filled with graft material, advanced through an Access Portal, and used with a Push Rod to facilitate manual deployment. The recalled units are identified by lot numbers CH20003 and BE22003, totaling 190 units.
The Graft Tube shaft may detach from the funnel head when the device is not used as instructed according to the manufacturer's Surgical Technique Guide. This potential detachment could compromise the surgical procedure.
The recalled product
- Product
- The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft material out of the Graft Tube and adjacent to where the…
- Manufacturer
- Spineology, Inc.
- Hazard
- Affected units
- 190
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 (4)
- UDI-DI: M7403120056
- Catalog Number: 312-0056
- part Number: 33-09-14. Lot Numbers: CH20003
- BE22003
Distribution
Distribution scope not specified by the agency.
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