MatrixNEURO Screws - Product Usage: The 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.
Reported: August 5, 2020 Initiated: June 18, 2020 #Z-2698-2020
Product Description
MatrixNEURO Screws - Product Usage: The 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.
Reason for Recall
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.
Details
- Recalling Firm
- Synthes, Inc.
- Units Affected
- 104 units
- Distribution
- International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
MatrixNEURO Screws - Product Usage: The 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.. Recalled by Synthes, Inc.. Units affected: 104 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2020. Severity: Moderate. Recall number: Z-2698-2020.
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