restor3d Inc. recall records

2 reported ongoing

5 records in this archive. Latest source date Jul 27, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006

Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for...

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, CO.

Official source for Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
FDA device enforcement

Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-s...

Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Class IIReported ongoing

Distribution: U.S. Nationwide distribution in the state of Texas.

Official source for Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Basepl...
FDA device enforcement

Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument

Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.

Class IIReported terminated

Distribution: US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

Official source for Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The ...
FDA device enforcement

Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument

During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

Class IIReported terminated

Distribution: US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

Official source for Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manua...
FDA device enforcement

Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument

During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

Class IIReported terminated

Distribution: US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

Official source for Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic ...

Reasons in these listed records

  • Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.
  • Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
  • Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
  • During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

These examples come from this result page and are not a ranking of every recall reason.

Checking restor3d Inc.

Is there a recall on restor3d inc. right now?

This archive contains 5 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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