Class II U.S. Food and Drug Administration

Arrowhead DE LLC Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525 recall: Implant did not undergo required gamma radiation dose audit. A potential

Recall published 2 months ago

Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2958-2026
Published
August 26, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Arrowhead DE LLC
Product type
Medical devices
Units affected
4,171
Distribution
Nationwide
Made in
United States
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
UPC codes
00855967006035, 00855967006042, 00855967006059, 00855967006066, 00855967006073, 00855967006080, 00855967006097, 00855967006110, 00855967006127, 00855967006134, 00855967006004, 00855967006011, 00855967006028, 00855967006141, 00855967006158, 00855967006165, 00855967006172, 00855967006189, 00855967006196

Products covered by this recall

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.

Check your product

The notice names 28 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00855967006035
  • 00855967006042
  • 00855967006059
  • 00855967006066
  • 00855967006073
  • 00855967006080
  • 00855967006097
  • 00855967006110
  • 00855967006127
  • 00855967006134
  • 00855967006004
  • 00855967006011
  • 00855967006028
  • 00855967006141
  • 00855967006158
  • 00855967006165
  • 00855967006172
  • 00855967006189
  • 00855967006196

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 21-253519
  • 00855967006035
  • 24662119
  • 242162

Model or item number

On the rating label, the box or the instruction sheet.

  • 21-253519
  • 21-253522
  • 21-253525
  • 21-253528
  • 21-2535

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Arrowhead DE LLC — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  3. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  4. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Arrowhead DE LLC — 401 Westpark Ct Ste 200, Peachtree City, GA, 30269-3572

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Arrowhead DE LLC medical devices recalled?

Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection. Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00855967006035, 00855967006042, 00855967006059; lot code 21-253519, 00855967006035, 24662119; model number 21-253519, 21-253522, 21-253525. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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