Synthes Low Profile Neuro System 3 mm Screws

• 2 recalls, same reason

  • Terminated Z-1327-2016 FDA Class II ·initiated 23 Feb 2016
  • Terminated Z-1326-2016 FDA Class II ·initiated 23 Feb 2016

  Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.

510(k) Number

K031807 ↗

FDA Product Code

DZL

Device Class

Class II

Regulation

21 CFR Part 872.4880

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Synthes Light Guide

  Class II

  FDA 510(k) K993314 Active Cleared 6 Dec 1999

• Synthes Locking Hand Plates

  Class II

  FDA 510(k) K092247 Active Cleared 25 Sep 2009

• Synthes Matrix Mis Rods

  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

• Synthes Lcp Proximal Tibia Plate

  Class II

  FDA 510(k) K011978 Active Cleared 9 Aug 2001

• Synthes Locking Calcaneal Plates

  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

See all devices from Synthes (Usa) →

• What procedures are these 3 mm screws designed for?

  The Synthes Low Profile Neuro System 3 mm screws are specifically engineered for intraosseous fixation in craniofacial, orthognathic, and reconstructive surgeries. They provide stable fixation for midface and craniofacial trauma cases, craniofacial surgery, and selective orthognathic procedures involving the maxilla or chin. Their low-profile design ensures minimal tissue disruption while maintaining secure bone alignment.

• Are these screws single-use or reusable?

  These screws are supplied as single-use, sterile devices. The design and regulatory classification (FDA 510(k) clearance) support their intended use in controlled, one-time surgical applications to ensure patient safety and sterility. Reuse is not recommended or approved for this product.

• What distinguishes the 3 mm screws from other sizes in the Low Profile Neuro System?

  The 3 mm screws are part of the Low Profile Neuro System, which offers various screw diameters and lengths. The 3 mm diameter is optimized for smaller bone fragments or areas requiring precise, low-profile fixation, such as delicate craniofacial reconstructions. Their smaller size reduces soft-tissue irritation while maintaining the strength needed for stable fixation in midface or chin procedures.

• How should these screws be stored to maintain sterility?

  As sterile, single-use devices, these screws must be stored in their original, unopened packaging in a clean, dry environment protected from moisture, dust, and direct sunlight. The packaging is designed to preserve sterility until first use. Avoid exposure to extreme temperatures or contamination sources, and adhere to the manufacturer’s expiration date to ensure performance and safety.

• What regulatory pathway does this device follow?

  The Synthes Low Profile Neuro System 3 mm screws are classified as Class II medical devices under FDA regulations and have received 510(k) clearance (K031807). This pathway confirms their substantial equivalence to a predicate device and ensures compliance with FDA safety and performance standards for dental fixation applications. The device is also regulated under the product code DZL and falls under the Dental advisory committee.