🔍 RecallPedia

Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

Class I - Dangerous
🏥 Medical Devices Recalled: August 9, 2019 Implant Direct Sybron Manufacturing Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Lot #135128 Exp: 3/12/20
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Implant Direct Sybron Manufacturing, LLC
Reason for Recall:
A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

Product Codes/Lot Numbers:

Lot #135128 Exp: 3/12/20

Distribution:

Distributed in: IN, VA, MD, TX, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0364-2020

Related Recalls

The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short  6-13mm depth, and Long  6-16mm depth), and in several diameters for different diameter drills.

Implant Direct Sybron Manufacturing

Class I - Dangerous

The Drill stop kit contains incorrect components.

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Implant Direct Sybron Manufacturing

Class I - Dangerous

Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

May 2, 2023 Other Medical Devices Nationwide View Details →