Reported Aug 5, 2020 · Terminated
MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial…
Synthes, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- MatrixNEURO Screws - Product UsageThe intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin
- Lot codes and dates
- Lot # 30P6198
- Amount recalled
- 104 units
Why it was recalled
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.
This product could cause temporary or reversible health problems — stop using it.
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