Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Numbers: 1600870-001, 1700470-001, 1700471-001.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.
Product Codes/Lot Numbers:
Model Numbers: 1600870-001, 1700470-001, 1700471-001.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0273-2014
Related Recalls
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Nobel Biocare Usa
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.
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Nobel Biocare Usa
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.
Packaged dental implant healing abutments were found to contain the wrong size device.