FDA recall Z-2067-2023

Product

LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21

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.

Key facts

Status

Ongoing

Initiation date

2022-12-23

Report date

2023-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norderstedt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2067-2023