FDA recall Z-2698-2020

Synthes, Inc. · Class II · device

Product

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.

Distribution

International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.

Key facts

Status
Terminated
Initiation date
2020-06-18
Report date
2020-08-05
Termination date
2021-04-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2698-2020