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
- Sterility
- 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
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
Is Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical recalled?
Yes. restor3d recalled Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical on 30 Mar 2022. The recall is Class II and its status is Terminated. Recall number Z-1026-2022.
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 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.
More recalls from restor3d
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|---|---|---|---|---|---|
| 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 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| 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 |