Tornier recalls AEQUALIS Humeral Nail Drill Bits (ref 7020140) with defective tips that may puncture sterile packaging, risking infection during surgery. Affected lot numbers listed.
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Tornier is recalling AEQUALIS Humeral Nail Drill Bits (ref 7020140) because some drill bit tips lack a new BargerGard protector, which could puncture sterile packaging and cause infection during surgery. This is a serious risk for medical procedures.
Drill bit tips without the BargerGard protector may puncture through sterile packaging during use. This could introduce contaminants into the surgical site, increasing infection risk for patients during procedures.
Orthopedic surgeons and medical staff using the AEQUALIS Humeral Nail system for bone fracture stabilization are most at risk. Patients undergoing surgery with this drill bit could face infection if the sterile packaging is punctured.
Check for the model number 7020140 on the drill bit packaging. Affected items were sold with lot numbers starting with BA0112130 through BA0615203.
Ensure the drill bit has a BargerGard protector; if missing, stop using it immediately.
Reach out to Tornier for guidance on safe handling or replacement options.
The drill bit tips may puncture sterile packaging without the BargerGard protector, risking infection during surgery.
Lot numbers starting with BA0112130 through BA0615203.
Look for the model number 7020140 on the drill bit packaging.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-1757-2018 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-1757-2018 from Tornier. 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.