Synthes, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Synthes, Inc.
Lot Codes / Batch Numbers
Lot # 30P6198
Products Sold
Lot # 30P6198
Synthes, Inc. is recalling MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
DePuy Synthes issued urgent field safety notice in June 2020 to notify customers. The affiliates in the impacted countries will notify affected customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026