🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: December 17, 2021 Nobel Biocare Usa Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)210720(17)260618; (01)07332747160529(10)13116497(11)210720(17)260618; Lot Numbers: 13116495, 13116496, 13116497
  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:
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.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Catalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)210720(17)260618; (01)07332747160529(10)13116497(11)210720(17)260618; Lot Numbers: 13116495, 13116496, 13116497

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0658-2022

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