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.
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
restor3d has recalled Evans Wedge Disposable Trials with medium footprint and 10mm thickness (model 6101-20181018) because parts got mixed into other lots during relabeling for a 4-year shelf life. This could lead to using the wrong parts in surgery.
During the relabeling process to extend the shelf life to four years, parts from different lots were accidentally mixed. This could mean using the wrong instrument parts in surgical procedures, potentially causing errors in treatment.
Orthopedic surgeons and medical facilities using the Evans Wedge Disposable Trials with model 6101-20181018. Those most at risk are healthcare professionals handling the instruments during surgery.
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.
Look for the model number 6101-20181018 on the instrument to confirm it is affected.
The product was recalled because parts got mixed into other lots during relabeling for a 4-year shelf life.
The affected model number is 6101-20181018.
Check for the model number 6101-20181018, lot number 2022010031, and unique device identifier 00840097501574.
We’ve drafted a message you can send restor3d to request your refund or repair — edit it as you like.
Subject: Recall Z-1027-2022 — restor3d restor3d Hello, I own a restor3d that is covered by recall Z-1027-2022 from restor3d. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
