Class II U.S. Food and Drug Administration

Xtant Medical Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm recall: Units from one lot were mislabeled with an incorrect part number

Recall published 6 months ago

Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.

The hazard: Mislabelling or misbranding

Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

What the notice says: Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

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-1773-2026
Published
April 15, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
XTANT Medical Holdings, Inc
Product type
Medical devices
Units affected
2 units
Distribution
Oregon
Made in
United States
Lot / code info
UDI/DI M697X0736555DL1, Lot Number 4375-01

Products covered by this recall

XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

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

  • 4375-01 — 2 units

Model or item number

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

  • X073-6555-DL. — UDI
  • DI M697X0736555DL1

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 Mislabelled

XTANT Medical Holdings, Inc — Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. Keep a photo of the mismatched label, which makes the refund conversation much shorter.
  3. Check the lot code on your pack — these mix-ups are usually confined to a short production window.
  4. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: XTANT Medical Holdings, Inc — 664 Cruiser Ln, Belgrade, MT, 59714-9719

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 XTANT Medical Holdings, Inc medical devices recalled?

Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 4375-01 — 2 units; model number X073-6555-DL. — UDI, DI M697X0736555DL1. 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?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Which states were affected?

The notice lists Oregon.

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