Reported Oct 23, 2024 · Ongoing
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced…
Spineology, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spineology, Inc. · 7800 3rd St N Ste 600 · Saint Paul, MN · 55128-5455
Is this the product you have?
- 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 implant is to be placed, as supported within the Surgical Technique Guide.
- Lot codes and dates
- UDI-DIM7403120056
- Catalog Number312-0056
- part Number33-09-14
- Lot Numbers
CH20003BE22003
- Amount recalled
- 190 units
Why it was recalled
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Spineology, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.