🔍 RecallPedia

ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

Class I - Dangerous
🏥 Medical Devices Recalled: August 7, 2018 Implant Direct Sybron Manufacturing Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Lot 108191, UDI (01)10841307108313(17)230118(10)108191
  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:
The incorrect device was packaged in the vial.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

Product Codes/Lot Numbers:

Lot 108191, UDI (01)10841307108313(17)230118(10)108191

Distribution:

Distributed in: AL, AZ, CA, CO, CT, FL, GA, ID, IL, KY, MA, MD, NM, NV, NY, PA, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0010-2020

Related Recalls

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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

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