Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540,
Summary
The FDA issued a Class II for Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-2535 by Arrowhead DE LLC. Reason: Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection..
Details
Source
Device Recall
External ID
Z-2958-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: REF/UDI-DI/Lot: 21-253519/00855967006035/24662119, 242162; 21-253522/00855967006042/24662122, 242163, 220702; 21-253525/00855967006059/24662125, 220703, 242164; 21-253528/00855967006066/24662128, 242165, 230704; 21-253530/00855967006073/242166, 230705, 220705; 21-253533/00855967006080/24662133, 242167, 230706; 21-253535/00855967006097/24662135, 242168, 230707; 21-253540/00855967006110/242169; 21-253545/00855967006127/242170; 21-253550/00855967006134/24662150; 21-353513/00855967006004/24662113, 242160; 21-353516/00855967006011/24662116, 230701, 242161; 27-253519/00855967006028/24662719, 242171; 27-253522/00855967006141/242172; 27-253525/00855967006158/242173; 27-253528/00855967006165/242174; 27-253530/00855967006172/242175; 27-253533/00855967006189/24662733, 242176; 27-253535/00855967006196/24662735, 242177
Quantity Affected: 4,171
Reason for Recall
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Distribution
US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-23
Company
Peachtree City, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Arrowhead DE LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Arrowhead DE LLC have FDA actions?
This is the only FDA action we have on record for Arrowhead DE LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2958-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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