Medicrea recalls IB3D PL Instruments Set (Rx Only) with serial numbers SPS03174 due to handle potentially untreading from shaft, causing inability to rotate implants.
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Medicrea is recalling its IB3D PL Instruments Set (Rx Only) with specific serial numbers because the rotation tool handle might detach from the shaft. This could prevent proper implant rotation during surgery, posing a risk to surgical outcomes.
The rotation tool handle may untread from the shaft during use, which can cause the instrument to become unable to rotate implants. This could lead to surgical complications if the tool fails during implant placement.
Orthopedic surgeons and medical professionals using the IB3D PL Instruments Set for surgical implant procedures. Those with the specific serial numbers listed are most at risk.
Check the serial number on the product label, which should be SPS03174. The affected units include specific lot numbers: 0001 through 0018 (excluding 0015 and 0019).
Look for the serial number SPS03174 on the product label to confirm if it is affected.
Reach out to Medicrea directly for further instructions or to confirm if your specific unit is affected.
The recall is due to complaints that the orthopedic rotation tool handle may untread from the shaft, causing the instrument to be unable to rotate implants during surgery.
The affected serial numbers are 0001 through 0018 (excluding 0015 and 0019), specifically listed as SPS03174.
No, but you should check the serial number and contact Medicrea to confirm if your unit is affected, as the hazard requires caution during use.
We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.
Subject: Recall Z-1039-2026 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-1039-2026 from Medicrea. 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.