FDA recall Z-1101-2023

Product

RipCord Syndesmosis Button, REF: STA001K

Reason for recall

Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.

Distribution

US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS

Key facts

Status

Ongoing

Initiation date

2022-12-22

Report date

2023-02-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Clarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2023