Lower riskMedical device recall · FDA · Published June 23, 2026
Arrowhead Implant Recall: Potential Infection Risk from Sterility Issues
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.
“Arrowhead Implant Recall: Potential Infection Risk from Sterility Issues.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/698016-arrowhead-implant-recall-potential-infection-risk-from-sterility-issues. Based on FDA recall #Z-2958-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2958-2026%22&limit=1).
The FDA announced on June 23, 2026, that Arrowhead DE LLC is recalling the Arrow-LOK Implant due to a potential reduction in sterility assurance. The hazard could lead to patient infection because the implant did not undergo a required gamma radiation dose audit.
The implant did not undergo a required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Context
GovInfoNow's records show other recent recalls of similar products include Arrow Recalls 18G Medical Kits Due to Possible Sterility Issues (2026-04-21) and Argon Medical Devices Bone Marrow Tray Recall: Sterility Risk (2026-06-01).
How to tell if you have this one
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.
Brand
Arrowhead
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Reference Numbers
Look for reference numbers like 21-253519, 21-253522, or other specific codes listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, Hawaii, New York, Tennessee, Texas, Vermont.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Is there a risk of serious injury from this implant?
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.
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.
Official source: FDA Recall #Z-2958-2026 (June 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2958-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.