Z-0520-2021 Class II Terminated
FDA device recall Z-0520-2021 was initiated by K2M, Inc on November 3, 2020 and is designated Class II. 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 interv… The recall status is terminated (terminated January 12, 2021). Affected quantity: 4 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- November 3, 2020
- Termination Date
- January 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 devices
Product Description
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.
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948