Arrowhead DE LLC recalls Arrow-LOK Implant due to potential reduction in sterility assurance, which could lead to patient infection. Affected units include specific reference numbers.
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Arrowhead DE LLC is recalling Arrow-LOK Implant devices because they did not undergo required gamma radiation dose audits, which might reduce sterility and cause infections. This recall affects specific product reference numbers used in foot surgeries.
The implant did not undergo required gamma radiation dose audits, which could lead to a reduction in sterility assurance. This means the device might not be sterile enough during surgery, increasing the risk of infection for patients.
Patients who received the Arrow-LOK Implant for foot procedures are likely affected. Those with the specific reference numbers listed in the recall are at risk of infection.
Check the product reference numbers listed in the recall, such as 21-253519, 21-253522, and other specific codes provided in the notice. The implant is used for foot procedures after corrective surgeries.
Look for reference numbers like 21-253519, 21-253522, or other specific codes listed in the recall notice.
The implant did not undergo required gamma radiation dose audits, which could lead to a reduction in sterility assurance and potentially cause patient infections.
Check the product reference numbers listed in the recall notice to see if your implant is affected. If it is, contact Arrowhead DE LLC for further instructions.
The recall states a potential reduction in sterility assurance could lead to infection, but no specific serious injury mechanism is mentioned. The danger level is low risk.
We’ve drafted a message you can send Arrowhead to request your refund or repair — edit it as you like.
Subject: Recall Z-2958-2026 — Arrowhead Arrowhead Hello, I own a Arrowhead that is covered by recall Z-2958-2026 from Arrowhead. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
