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 reco
Check against the official notice below — it lists the full affected range.
Arrowhead DE LLC is recalling 4,171 Arrow-LOK Implants because the devices did not undergo a required gamma radiation dose audit. Without this sterilization verification process, the implants may have reduced sterility assurance, which could potentially lead to patient infection. The affected implants were distributed nationwide across Vermont, Florida, Tennessee, New York, Georgia, Texas, and Hawaii, with multiple lot numbers and reference codes identified.
The recall encompasses specific lot and code information for various implant models (references 21-253519 through 27-253535). However, the source does not specify a remedy or what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Reason for recall: Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection. Distribution: US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI. Quantity: 4,171 Lot/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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.