DePuy Mitek recalls screw and washer depth gauges with a 3.2mm reading error that may lead to incorrect bone hole measurements during surgery.
The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
DePuy Mitek is recalling screw and washer depth gauges that measure approximately 3.2mm shorter than the actual bone hole length. This error could cause incorrect surgical measurements, potentially leading to complications during orthopedic procedures.
The depth gauge has a design offset that causes it to read about 3.2mm shorter than the actual bone hole length. This could result in surgeons using the wrong measurement during surgery, potentially causing improper implant placement.
Orthopedic surgeons and medical professionals who use the recalled depth gauges for bone hole measurements. The risk is low as the error is a small measurement discrepancy rather than a safety hazard.
Check for the product code 219024 on the device. The lot numbers listed in the recall include 0005178, 1103107, and other specific numbers. The device was sold with a unique identifier (UDI) starting with 10886705005390.
Look for the product code 219024 and the listed lot numbers on the device.
The device has a design offset that results in a reading approximately 3.2mm shorter than the actual bone hole length, which could lead to incorrect surgical measurements.
Check for the product code 219024 and the specific lot numbers listed in the recall, including 0005178, 1103107, and others.
The recall does not specify a remedy, so contact DePuy Mitek directly for guidance.
We’ve drafted a message you can send DePuy Mitek to request your refund or repair — edit it as you like.
Subject: Recall Z-0208-2019 — DePuy Mitek DePuy Mitek Hello, I own a DePuy Mitek that is covered by recall Z-0208-2019 from DePuy Mitek. 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.
