restor3d recalls orthopedic surgical instruments with mixed parts during relabeling for 4-year shelf life. Affected models include 6101-22200818. No remedy specified in official notice.
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 orthopedic surgical instruments that may have mixed parts during relabeling for a 4-year shelf life. This could lead to incorrect instrument use in surgeries. The recall does not include a remedy.
During the relabeling process for a 4-year shelf life, parts were accidentally mixed into other lots. This could mean the instruments have incorrect components, potentially leading to improper surgical use.
Orthopedic surgeons and surgical teams using the specific model 6101-22200818 instruments. Those with the lot number 2022010035 or UDI 00840097501598 are most at risk.
Check for the model number 6101-22200818 on the instrument. Look for lot number 2022010035 or unique device identifier (UDI) 00840097501598.
Verify the model number, lot number, and UDI on the instrument to confirm if it's affected.
The official recall notice does not specify any remedy.
The affected model is 6101-22200818.
Check for lot number 2022010035 or unique device identifier (UDI) 00840097501598.
We’ve drafted a message you can send restor3d to request your refund or repair — edit it as you like.
Subject: Recall Z-1028-2022 — restor3d restor3d Hello, I own a restor3d that is covered by recall Z-1028-2022 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.
