CLASS II Device recall · Reported 9 Dec 2020 · FDA Enforcement Report
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube recalled by K2M
K2M is recalling Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube, distributed nationwide in the US. The recall was initiated on 3 Nov 2020 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-0520-2021
- FDA event ID
- 86748
- Recalling firm
- K2M, Leesburg, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Nov 2020
- FDA classified
- 2 Dec 2020
- Reported
- 9 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 3 Nov 2020 | Recall initiated by company | |
| 2 Dec 2020 | Classified by FDA | +29 days |
| 9 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.
Product as listed by the FDA
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.
Which lots are affected?
Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948
Where was it sold?
US Nationwide distribution.
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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