Z-2698-2020 Class II Terminated
FDA device recall Z-2698-2020 was initiated by Synthes, Inc. on June 18, 2020 and is designated Class II. 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 identi… The recall status is terminated (terminated April 13, 2021). Affected quantity: 104 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- June 18, 2020
- Termination Date
- April 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104 units
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.
Distribution Pattern
International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
Code Information
Lot # 30P6198