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.
This recall has been terminated (originally issued June 18, 2020).
- Company
- Synthes, Inc.
- Recall Initiated
- June 18, 2020
- Terminated
- April 13, 2021
- Recall Number
- Z-2698-2020
- Quantity
- 104 units
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot # 30P6198
Root Cause
Under Investigation by firm
Action Taken
DePuy Synthes issued urgent field safety notice in June 2020 to notify customers. The affiliates in the impacted countries will notify affected customers.
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