Neosteo recalls 1.9mm cannulated drill bits with AO QC system (lot 243-20) due to corrosion traces that may cause inflammation, pain, or allergic reactions during orthopedic surgery.
Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the operated area, potentially leading to the following risks: Inflammation, pain, allergy, adverse tissue reaction. Device description: The drill bit is used to create the hole required for the introduction of the screw, it is suitable for Neosteo compression screws for cortical and spongy bone. Drilling depth can be read on the instrument. The shaft is coupled with the ¿4.5mm surgical motor using a AO ¿4.5mm male drive connexion. The countersink bit is coupled to a ¿1.0mm k-wire to ensure guiding while drilling. The instrument is packaged in a plastic sheath sealed by welding.
Neosteo is recalling 1.9mm cannulated drill bits used in orthopedic surgery because corrosion traces could cause inflammation, pain, or allergic reactions during surgery. This affects surgeons and medical staff who use these tools for bone procedures.
Corrosion traces on the drill bit can release particles during surgery that may cause inflammation, pain, or allergic reactions in patients. This happens because the drill bit is used to create holes for screws in bone, and corrosion particles can enter the surgical site.
Surgeons and medical staff who use Neosteo's 1.9mm cannulated drill bits for orthopedic surgery are most at risk. The recall applies to specific surgical tools used in bone procedures.
Check for the Neosteo brand, 1.9mm diameter, with AO QC system (reference INS-114), and lot number 243-20. These drill bits are used in orthopedic surgery for bone procedures.
Inspect the drill bit for visible corrosion or wear marks, especially on the shaft where it connects to the surgical motor.
Reach out to Neosteo directly to request a replacement drill bit if corrosion is found or if you have the specific lot number 243-20.
Neosteo recalled these drill bits because traces of corrosion were detected, which could lead to the emission of particles during surgery that might cause inflammation, pain, or allergic reactions.
The drill bit has a reference number INS-114 and lot number 243-20.
No, but you should check for corrosion traces and contact Neosteo if you have the specific lot number 243-20 to get a replacement.
We’ve drafted a message you can send Neosteo to request your refund or repair — edit it as you like.
Subject: Recall Z-2236-2021 — Neosteo Neosteo Hello, I own a Neosteo that is covered by recall Z-2236-2021 from Neosteo. 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.
