restor3d Veritas Standard Glenoid Baseplate Recall

Source: FDA · Texas, 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.

restor3d Inc. is recalling 59 units of Veritas Standard Glenoid Baseplate devices due to incorrect machining of peripheral screw holes.

FDA recall: what the record actually shows

This notice was issued by FDA on September 8, 2026 and geographically references Texas, United States. The FDA classifies this as a Class II recall, with the stated reason "Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.", distributed u.s. nationwide distribution in the state of texas.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. 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.

It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.

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

restor3d Inc. initiated a recall due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Which Products Are Affected

The recall affects the Veritas Standard Glenoid Baseplate component of the Veritas Standard Reverse Total Shoulder system. Affected models include:

  • Model/Catalog Number 1500-1030 (UDI-DI 00840097513225), Lot Numbers A00030, A00065, A09828, A09830
  • Model/Catalog Number 1500-1035 (UDI-DI 00840097513232), Lot Numbers A00064, A09829 A total of 59 units are affected. Distribution was U.S. Nationwide distribution in the state of Texas. The recall number is Z-2987-2026.

What You Should Do

No specific consumer action steps are provided in the recall notice.

Why This Matters

This Class II recall involves a device component where the defect could lead to improper screw engagement in shoulder replacement procedures.

Source

FDA recall Z-2987-2026

Original source: FDA Official Notice ↗

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Two cross-category peer sets, both computed from Areazine's own archive: notices with a similar body length, and notices near the same severity and agency date. These are drawn from other categories, not the same-feed Related list above.

Frequently Asked Questions

What people usually ask about a notice like this one.

What is this FDA recall about?
restor3d Inc. is recalling 59 units of Veritas Standard Glenoid Baseplate devices due to incorrect machining of peripheral screw holes.
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 is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects Texas, 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.