Device recall
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.
- Recall number
- Z-2958-2026
- Event id
- 99383
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Arrowhead DE LLC
- Report date
- Aug 26, 2026
- Initiated
- Jun 23, 2026
- Center classification date
- Aug 14, 2026
- Reason
- Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
- Quantity
- 4,171
- Code info
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Peachtree City, GA, United States