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
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
- 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 AlabamaIndianaKentuckyNorth CarolinaNew JerseyTexasVirginia
Questions about this recall
Is Evans Wedge Disposable Trials, Large Footprint Thickness ( recalled?
Yes. restor3d recalled Evans Wedge Disposable Trials, Large Footprint Thickness ( on 30 Mar 2022. The recall is Class II and its status is Terminated. Recall number Z-1028-2022.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |