Arrow-LOK Implant recall — Arrowhead DE LLC
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Official ID Z-2958-2026 · Official record ↗
Recall found. Arrowhead DE is named in FDA Class II recall Z-2958-2026 covering Arrow-LOK Implant. Hazard: Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection. Identifying details: 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. Status: Ongoing.
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Official ID Z-2958-2026 · Official record ↗
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Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.