Arrow-LOK Implant Recall Over Sterility Assurance
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Arrowhead DE LLC is recalling 4,171 Arrow-LOK Implants due to failure to undergo required gamma radiation dose audit, potentially reducing sterility assurance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 10, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.", distributed us nationwide distribution in the states of vt, fl, tn, ny, ga, tx, hi.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Arrowhead DE LLC initiated a voluntary recall of Arrow-LOK Implants because the products did not undergo the required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Which Products Are Affected
The recall covers 4,171 units of Arrow-LOK Implant with the following REF 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. Specific lot and UDI-DI details are listed in FDA recall Z-2958-2026. Distribution was nationwide in the United States, including the states of VT, FL, TN, NY, GA, TX, and HI.
What You Should Do
The recalling firm notified customers via email, fax, letter, press release, telephone, and visit. Contact Arrowhead DE LLC at 401 Westpark Ct Ste 200, Peachtree City, GA 30269-3572 for additional information.
Why This Matters
The recall addresses a potential reduction in sterility assurance for implants used in lesser toe fixation procedures, which could lead to patient infection.
Source
FDA recall number Z-2958-2026, Class II, event ID 99383.
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,220 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.