Recall Z-2958-2026— Arrowhead DE LLC

Name: FDA recall Z-2958-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-23

Class II · Ongoing

Class II FDA medical device recall by Arrowhead DE LLC, initiated 2026-06-23. It names one FDA 510(k) clearance: K112675. 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: Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection..

Recalling firm: Arrowhead DE LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-06-23
Firm location: Peachtree City, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K112675 — ARROW-LOK DIGITAL SYSTEMArrowhead Medical Device Technologies, LLC·cleared 2011-12-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.