Recall of XTANT Medical Xpress Pedicle Screw System

Source: FDA · Oregon, United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

XTANT Medical Holdings, Inc. is recalling 2 units of the Xpress Pedicle Screw System due to mislabeling that incorrectly identifies the screw length.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 22, 2026 and geographically references Oregon, United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

XTANT Medical Holdings, Inc. initiated a voluntary recall because units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it actually is.

Which Products Are Affected

The affected product is the XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, with Part Number X073-6555-DL. The recall involves 2 units, specifically those with UDI/DI M697X0736555DL1 and Lot Number 4375-01. This recall is limited to distribution in Oregon, United States, under recall number Z-1773-2026.

What You Should Do

Consumers should contact XTANT Medical Holdings, Inc. at their address, 664 Cruiser Ln, Belgrade, MT 59714-9719, as the initial notification was made via letter. Follow any instructions provided by the firm for returns or further actions.

Why This Matters

This recall addresses a potential risk from mislabeling a medical device, which could lead to incorrect use in procedures and affect patient safety, though it is classified as Class II indicating a remote chance of serious harm.

Source

This information is from the FDA recall database, attributed to recall number Z-1773-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
XTANT Medical Holdings, Inc. is recalling 2 units of the Xpress Pedicle Screw System due to mislabeling that incorrectly identifies the screw length.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Oregon, United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.