Gramercy recalls GEO Instrument Kit for EPS Plate (REF: 70120001) due to drill guides with incorrect depth range (30-60mm vs required 10-40mm). This may cause improper bone fixation during surgery.
Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm.
Gramercy Extremity Orthopedics recalls their GEO Instrument Kit for EPS Plate (REF: 70120001) because some drill guides have the wrong depth range (30-60mm instead of 10-40mm). Using these could lead to improper bone fixation during surgery.
The drill guides in some instrument kits have a depth range of 30-60mm instead of the required 10-40mm. This incorrect range could cause improper bone fixation during surgery, potentially leading to complications.
Orthopedic surgeons and medical professionals who use the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System. Those who have the specific instrument kit with the listed serial numbers are most at risk.
Check if your instrument kit has the model reference 70120001 and serial numbers listed in the recall (e.g., 1022000493, 1022000623, etc.). These are part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System.
Verify if your GEO Instrument Kit for EPS Plate has the model reference 70120001 and the listed serial numbers.
The drill guides in some instrument kits have an incorrect depth range (30-60mm) instead of the required 10-40mm, which could cause improper bone fixation during surgery.
The recall does not specify a remedy. Check if your instrument kit has the model reference 70120001 and the listed serial numbers to determine if it's affected.
Look for the model reference 70120001 and serial numbers listed in the recall (e.g., 1022000493, 1022000623, etc.).
We’ve drafted a message you can send Gramercy Extremity Orthopedics to request your refund or repair — edit it as you like.
Subject: Recall Z-1395-2023 — Gramercy Extremity Orthopedics Gramercy Extremity Orthopedics Hello, I own a Gramercy Extremity Orthopedics that is covered by recall Z-1395-2023 from Gramercy Extremity Orthopedics. 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.
