Arrow-LOK Implant
Arrowhead recalls Arrow-LOK Implants over missing gamma radiation audit, risking infection.
Do not use the affected Arrow-LOK Implants. Contact Arrowhead DE LLC for instructions on returning the product and obtaining a replacement.
Why it was recalled
Arrowhead DE LLC is recalling Arrow-LOK Implants used for fixation of osteotomies, arthrodeses, and reconstruction in the lesser toes because they did not undergo the required gamma radiation dose audit, which could reduce sterility assurance and lead to patient infection.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Lot code | UDI-DI |
|---|---|---|
| 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. | – | 00855967006035, 24662119, 00855967006042, 24662122, 00855967006059, 24662125, 00855967006066, 24662128, 00855967006073, 00855967006080, 24662133, 00855967006097, 24662135, 00855967006110, 00855967006127, 00855967006134, 24662150, 00855967006004, 24662113, 00855967006011 |
| Arrow-LOK Implant, REF | 21-253519, 24662119, 242162 | 00855967006035 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Sterility Failure recalls
Editorial summary by Recall Canary · summary updated 2026-08-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification