Recall Z-2698-2020— Synthes, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes, Inc., initiated 2020-06-18, terminated 2021-04-13. It names one FDA 510(k) clearance: K042365. 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: 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..
- Recalling firm
- Synthes, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-18
- Terminated
- 2021-04-13
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.