CLASS II Device recall · Reported 11 May 2022 · FDA Enforcement Report

Evans Wedge Disposable Trials, Large Footprint Thickness recalled

restor3d is recalling Evans Wedge Disposable Trials, Large Footprint Thickness (, distributed nationwide in the US. The recall was initiated on 30 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 6101-22200818; Lot: 2022010035; UDI: 00840097501598

Quantity recalled9 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1028-2022
FDA event ID: 89983
Recalling firm: restor3d, Durham, NC
Classification: Class II
Status: Terminated
Recall initiated: 30 Mar 2022
FDA classified: 29 Apr 2022
Reported: 11 May 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

30 Mar 2022	Recall initiated by company
29 Apr 2022	Classified by FDA	+30 days
11 May 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Alabama Indiana Kentucky North Carolina New Jersey Texas Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 89983

This product is part of a recall event; the main page for the event is Evans Wedge Disposable Trials, Medium Footprint Thickness recalled.

Reported	Class	Recall	Company	Reason	Where
11 May 2022	CLASS II	Evans Wedge Disposable Trials, Medium Footprint Thickness recalled	restor3d	Other	Nationwide
11 May 2022	CLASS II	Non-Sterile Double Ended Trial Kit, Small Footprint recalled by restor3d	restor3d	Other	Nationwide

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All 5

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11 May 2022Device	CLASS II	Non-Sterile Double Ended Trial Kit, Small Footprint recalled by restor3d	restor3d	Other	Nationwide
11 May 2022Device	CLASS II	Evans Wedge Disposable Trials, Medium Footprint Thickness recalled	restor3d	Other	Nationwide

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