🔍 RecallPedia

NobelReplace CC NP 3.5x10mm, Article No. 36700.

Class I - Dangerous
🏥 Medical Devices Recalled: March 9, 2015 Nobel Biocare Usa Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Batch No. 13010971, 13010972, 13010976, 13011142, 13011771, 13011772, 13011828, 13011830, 13012480, 13012481, 13012482, 13012640.
  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:
Nobel Biocare Usa Llc
Reason for Recall:
A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

NobelReplace CC NP 3.5x10mm, Article No. 36700.

Product Codes/Lot Numbers:

Batch No. 13010971, 13010972, 13010976, 13011142, 13011771, 13011772, 13011828, 13011830, 13012480, 13012481, 13012482, 13012640.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1425-2015

Related Recalls

NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

Nobel Biocare Usa

Class I - Dangerous

Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.

Dec 17, 2021 Other Medical Devices Nationwide View Details →

NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

Nobel Biocare Usa

Class I - Dangerous

The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.

Jul 19, 2019 Implants & Prosthetics Nationwide View Details →

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

Nobel Biocare Usa

Class I - Dangerous

Packaged dental implant healing abutments were found to contain the wrong size device.

May 28, 2019 Implants & Prosthetics Nationwide View Details →