Lower riskMedical device recall · FDA · Published March 30, 2022
restor3d Evans Wedge Disposable Trials: Mixed Parts Risk During Relabeling
restor3d recalls Evans Wedge Disposable Trials (6101-20181018) due to parts mixing during relabeling for 4-year shelf life. Affected units have specific model and lot numbers.
“restor3d Evans Wedge Disposable Trials: Mixed Parts Risk During Relabeling.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60865-restor3d-evans-wedge-disposable-trials-mixed-parts-risk-during-relabeling. Based on FDA recall #Z-1027-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1027-2022%22&limit=1).
restor3d Inc. recalled Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018) due to parts being mixed into other lots during re-work for relabeling, the FDA said on March 30, 2022.
How to tell if you have it
Brand: restor3d
Product: Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018)
Model: 6101-20181018
Lot: 2022010031
UDI: 00840097501574
The hazard
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Context
GovInfoNow's records show restor3d Inc. has 2 other recalls on record since 2026-06-30. The company issued the restor3d Kinos Axiom Ankle Implant Recall on July 27, 2026, involving incorrect patient-specific cutting guides. On June 30, 2026, restor3d recalled the Veritas Standard Glenoid Baseplate due to improper screw engagement risk. Other recent recalls of similar products include the Tornier Perip Screw Recall (Dec. 19, 2025), Howmedica Triathlon Baseplate Size 3 Recall (May 19, 2026), and Straumann Custom Abutment AS Ti Recall (March 17, 2026).
How to tell if you have this one
Check for the model number 6101-20181018 on the instrument. The lot number is 2022010031 and the unique device identifier (UDI) is 00840097501574. This product was sold in 2022.
Brand
restor3d
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Recall number
Product, codes & lots
Quantity
Z-1026-2022
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument; Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506
Look for the model number 6101-20181018 on the instrument to confirm it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Indiana, Kentucky, New Jersey, North Carolina, Texas, Virginia.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1027-2022 (March 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1027-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.