FDA recall Z-2958-2026

Arrowhead DE LLC · Class II · device

Product

Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures.

Reason for recall

Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

Distribution

US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.

Key facts

Status
Ongoing
Initiation date
2026-06-23
Report date
2026-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Peachtree City, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2958-2026