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ARROW-LOK 1 (REF 21-253530)Recalls & reported problems

Arrowhead De LLC · ARROW-LOK 2.5-3.5mm / Length 30mm, Straight · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 23, 2026Open, Classified

    Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

    Z-2958-2026 · Root cause: Process change control · FDA record ↗

Other Pin, Fixation, Smooth devices

All Pin, Fixation, Smooth devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.