LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
- Recall Initiated
- December 23, 2022
- Posted
- July 3, 2023
- Recall Number
- Z-2066-2023
- Quantity
- 20 units
Reason for Recall
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Distribution
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
Lot / Code Info
UDI-DI: 04026575257379 Lot Number: 2123225
Root Cause
Component change control
Action Taken
LinkBio Corporation issued A Product Advisory Notice to consignees holding field inventory on 18-May-2023. The product is provided to the surgeon directly by the representative of the Distributor. Letter states reason for recall, health risk and action to take: Please ensure the surgical team is made aware of this issue before using one of the affected augments. While there is no safety impact due to this issue, there could be some confusion during assembly if the issue is not known in advance. No additional action is required by users beyond reinserting the screw in the correct orientation, and no product return is required at this time. Please contact your LinkBio Sales or Customer Service representative or the contact for any questions: Jennifer Lubrecht Senior Director, Quality Management LinkBio Corporation 69 King Street Dover, NJ 07801 Mobile: +1 862.477.0370 Email: j.lubrecht@LinkBio.com