Recall of XTANT Medical Xpress Pedicle Screw System
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 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, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →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 (1,186 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 22, 2026.
Frequently Asked Questions
Common questions about this FDA recall.