Arrow-LOK Implant — Class II medical device recall Z-2958-2026

Ongoing recall by Arrowhead DE LLC, reported 2026-08-26, distributed nationwide. Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance coul

Recall number	`Z-2958-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Arrowhead DE LLC, Peachtree City, GA, United States
Recall initiated	2026-06-23
Classified	2026-08-14
Reported by FDA	2026-08-26
Distributed	Nationwide (US)
Quantity	4,171
Reason classes	sterility
UPC / GTIN / UDI-DI	`00855967006004`, `00855967006011`, `00855967006028`, `00855967006035`, `00855967006042`, `00855967006059`, `00855967006066`, `00855967006073`, `00855967006080`, `00855967006097`, `00855967006110`, `00855967006127`, `00855967006134`, `00855967006141`, `00855967006158`, `00855967006165`, `00855967006172`, `00855967006189`, `00855967006196`
Lot numbers	`220702`, `220703`, `220705`, `230701`, `230704`, `230705`, `230706`, `230707`, `242160`, `242161`, `242162`, `242163`, `242164`, `242165`, `242167`, `242168`, `242171`, `242176`, `242177`
Model numbers	`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`

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.

Reason for recall

Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2958-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.