Medical Device Recall: 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, 27-2535
Arrowhead DE LLC · June 23, 2026
Reason for Recall
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Product Description
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.
Distribution
US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.
States Affected
NATIONWIDE
Quantity Affected
4,171
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2958-2026
Status: ongoing
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