Reported Aug 26, 2026 · Ongoing · Updated Sep 7, 2026
Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540,…
Arrowhead DE LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arrowhead DE LLC · 401 Westpark Ct Ste 200 · Peachtree City, GA · 30269-3572
Is this the product you have?
- Arrow-LOK Implant
- REF21-253519, 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
- Lot codes and dates
19 of 19 products · 38 lot codes
Recalled lot codes, grouped by product number REF UDI-DI Lot 21-2535190085596700603524662119242162
21-2535220085596700604224662122242163220702
21-2535250085596700605924662125220703242164
21-2535280085596700606624662128242165230704
21-25353000855967006073242166230705220705
21-2535330085596700608024662133242167230706
21-2535350085596700609724662135242168230707
21-25354000855967006110242169
21-25354500855967006127242170
21-2535500085596700613424662150
- Amount recalled
- 4,171
Where it was sold
Why it was recalled
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
This product could cause temporary or reversible health problems — stop using it.
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