Z-2698-2020Class II

MatrixNEURO Screws -

Name: Z-2698-2020 MatrixNEURO Screws -
Creator: Synthes, Inc.
Published: 2020-06-18
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2020-06-18 / Terminated / root cause: labeling and UDI

FDA source

Synthes, Inc. began a recall of MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies... on 2020-06-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2698-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-18
Posted: 2020-07-24
Terminated: 2021-04-13
Recalling firm: Synthes GmbH
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.
Product code: JEY Plate, Bone
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 104 units
Distribution: International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
Product codes and lots: Lot # 30P6198

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2698-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2698-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-24

Product code JEY

K042365Class IISynthes (USA) Neuro Plate and Screw SystemSynthes (Usa) / cleared 2004-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)