Implant Recall: Arrowhead DE Arrow-LOK
Announced 2026-08-26 · FDA
FDA is recalling Arrowhead DE LLC’s Arrow-LOK Implant. The implant did not undergo the required gamma radiation dose audit, which could reduce sterility assurance and potentially cause infection. About 4,171 implants were distributed nationwide in VT, FL, TN, NY, GA, TX, and HI.
| Brand | Arrowhead DE LLC |
|---|---|
| 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. |
| Severity | moderate |
| Units affected | 4171 |
| Distribution | US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI. |
| Agency | FDA |
| Recall / campaign no. | REF/UDI-DI/Lot: 21-253519/00855967006035/24662119, 242162; 21-253522/00855967006042/24662122, 242163, 220702; 21-253525/00855967006059/24662125, 220703, 242164; 21-253528/00855967006066/24662128, 242165, 230704; 21-253530/00855967006073/242166, 230705, 220705; 21-253533/00855967006080/24662133, 242167, 230706; 21-253535/00855967006097/24662135, 242168, 230707; 21-253540/00855967006110/242169; 21-253545/00855967006127/242170; 21-253550/00855967006134/24662150; 21-353513/00855967006004/24662113, 242160; 21-353516/00855967006011/24662116, 230701, 242161; 27-253519/00855967006028/24662719, 242171; 27-253522/00855967006141/242172; 27-253525/00855967006158/242173; 27-253528/00855967006165/242174; 27-253530/00855967006172/242175; 27-253533/00855967006189/24662733, 242176; 27-253535/00855967006196/24662735, 242177 |
WHAT YOU SHOULD DO
- Contact your surgeon or healthcare provider to discuss the recall and any potential risks.
- Do not attempt to remove or alter the implant yourself; follow your clinician's instructions.
- Check with the implant facility or manufacturer for monitoring or replacement options.
- Seek medical attention if you develop signs of infection around the surgical site or have concerns about your implant.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.