FDA recall Z-1674-2023

Product

LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13

Reason for recall

Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).

Distribution

US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX

Key facts

Status

Ongoing

Initiation date

2023-04-25

Report date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockaway, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1674-2023