FDA Medical Device Recalls (openFDA)
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 number
- Z-2698-2020
- Recalling firm
- Synthes, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-06-18
- Posted
- not on file
- Terminated
- 2021-04-13
- 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.
- Root cause
- Under Investigation by firm
- Action
- DePuy Synthes issued urgent field safety notice in June 2020 to notify customers. The affiliates in the impacted countries will notify affected customers.
- Quantity
- 104 units
- Distribution
- International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
- Lot, serial or model codes
- Lot # 30P6198
- 510(k) numbers
- ["K042365"]
- PMA numbers
- not on file
- Product code
- JEY
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28