Class II — Arrowhead DE LLC
| Recalling firm | Arrowhead DE LLC |
|---|---|
| Registered facility | ARROWHEAD DE LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection. |
| 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. |
| Quantity | 4,171 |
| Distribution | US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI. |
| Initiated | 2026-06-23 |
| Classified | 2026-08-14 |
| Recall number | Z-2958-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Arrowhead DE LLC (Z-2958-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99383/
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