The Recall Desk
HighFDA (Devices)·Z-2236-2021·Announced 2021-08-18

Orthopedic drill bit recalled for corrosion particle contamination risk

NEOSTEO cannulated drill bits are being recalled due to corrosion traces on the laser marking that could release particles into the surgical field. The recall affects Lot 243-20 distributed in New Jersey.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall. The source does not report any illnesses or injuries to date. However, the detected corrosion defect presents a risk-of-harm in a surgical context (potential for inflammation, allergic reaction, and adverse tissue response), which elevates this to High severity despite the absence of reported incidents.

Plain-English summary

NEOSTEO is recalling Cannulated Graduated Drill Bits (1.9 mm diameter, REF: INS-114) due to traces of corrosion detected on the laser marking. The affected lot is 243-20, distributed in New Jersey. This surgical instrument is used in orthopedic procedures to prepare bone for screw placement.

The corrosion on the laser marking could cause wear and corrosion particles to be released during the drilling procedure. If these particles contact bone and adjacent tissue during surgery, they could potentially cause inflammation, pain, allergic reaction, or adverse tissue response.

Healthcare providers and surgical facilities should immediately remove drill bits from Lot 243-20 from service. Contact NEOSTEO regarding proper return procedures.

The recalled product

Product
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Manufacturer
NEOSTEO
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
  • corrosion
  • particle-contamination
  • allergic-reaction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 243-20

Distribution

Distributed nationwide across the United States.

Related recalls

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