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Arrowhead DE LLC recalls Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540,
Recalled August 26, 2026 · FDA recall Z-2958-2026 · Arrowhead DE
Hazard
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection. · FDA Class II
Units
4,171
Sold at
US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.
Description
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
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.
Manufacturer(s)
Arrowhead DE LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →