CLASS II Device recall · Reported 11 May 2022 · FDA Enforcement Report
Non-Sterile Double Ended Trial Kit, Small Footprint recalled by restor3d
restor3d is recalling Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical, 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-1026-2022
- 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
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Product as listed by the FDA
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. 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
Why was it recalled?
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Which lots are affected?
Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506
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 89983This 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 |
|---|---|---|---|---|---|
| CLASS II | Evans Wedge Disposable Trials, Medium Footprint Thickness recalled | restor3d | Other | Nationwide | |
| CLASS II | Evans Wedge Disposable Trials, Large Footprint Thickness recalled | restor3d | Other | Nationwide |
More recalls from restor3d
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide) recalled | restor3d | Packaging Defects | Nationwide |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Evans Wedge Disposable Trials, Large Footprint Thickness recalled | restor3d | Other | Nationwide |
| Device | CLASS II | Evans Wedge Disposable Trials, Medium Footprint Thickness recalled | restor3d | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |