Arrowhead DE Arrow-LOK toe implants recalled over sterility risk
Arrowhead DE LLC is recalling certain Arrow-LOK implants used to fix bones in the lesser toes after corrective surgery. The implants did not complete a required gamma radiation dose audit, which could reduce their sterility and potentially lead to patient infection. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- If you had lesser toe surgery with an Arrow-LOK implant, contact your surgeon or healthcare provider.
- Check the REF and lot numbers on your implant records against the recall list.
- Report redness, swelling, drainage, or fever at the surgical site to your provider promptly.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- Adults (18 years to 100 years)
Details
- Units affected
- 4,171
- Illnesses reported
- None reported
- Manufactured in
- 401 Westpark Ct Ste 200, Peachtree City, GA, United States
- Classification
- Class II
- Recall number
- Z-2958-2026
In the FDA's words
- 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. Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection. 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 Distribution: US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI. Affected quantity: 4,171
- Hazard
- Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.