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.
Z-2698-2020
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 85899
- Status
- Terminated
- Classification
- Class II
- Quantity
- 104 units
- Official record key
device-enforcement:Z-2698-2020
Official wording
Reason: 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.
Code information: Lot # 30P6198
Distribution pattern: International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
Derived failure modes
-
Unknown
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.