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.
FDA Recall Z-2958-2026 · Posted 2026-08-14
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Recalling FirmArrowhead DE LLC
Recall StatusOpen, Classified
Product CodeHTY
Date Initiated2026-06-23
Product Quantity4,171
Reason for Recall
Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Firm Action
On 6/23/2026 customers were phoned and informed to return affected implants.
On 7/7/2026, recall notices were mailed to risk managers who were asked to do the following:
1) Cease use, distribution, and quarantine affected product.
2) Contact firm customer service to obtain instructions for returning product.
3) Email mail tracking numbers to firm.
4) Complete and return the acknowledgement and receipt form.
Questions can be directed to the firm at 470-419-1429
Root Cause
Process change control
Distribution Pattern
US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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