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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Straumann WB XL Anatomic Healing Abutment XC Recalled for Incorrect Labeling

Agency Publication Date: April 24, 2025
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Summary

Straumann USA LLC is recalling ,1786 units of WB XL Anatomic Healing Abutment XC, which are components used in dental implant procedures. The recall was initiated because the blister packaging for these endosseous dental implant abutments contains incorrect labeling. No incidents or injuries have been reported to date, but the firm has voluntarily initiated this recall to ensure patient safety and correct product identification.

Risk

Incorrect labeling on the packaging could lead a clinician to select and use an improper abutment size or type during surgery. This mismatch can cause surgical delays or lead to sub-optimal placement of the dental implant components.

What You Should Do

  1. This recall affects Straumann WB XL Anatomic Healing Abutment XC (Endosseous Dental Implant Abutments) with Article Numbers 064.4522S and 064.4523S.
  2. Check your inventory for lot numbers GNNA2, JZYZ3, KRJA6, GJXT4, JLLP9, KCKL1, KPRE4, and LWZM6, which have expiration dates between June 2029 and February 2030. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Straumann USA LLC or your dental supply distributor to arrange for the return, replacement, or correction of the affected products.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: WB XL Anatomic Healing Abutment XC
Model / REF:
064.4522S
064.4523S
Lot Numbers:
GNNA2 (Exp 6/12/29)
JZYZ3 (Exp 11/14/29)
KRJA6 (Exp 12/15/29)
GJXT4 (Exp 6/3/29)
JLLP9 (Exp 10/10/29)
KCKL1 (Exp 11/19/29)
KPRE4 (Exp 12/10/29)
LWZM6 (Exp 2/18/30)
UDI:
07630031775856
07630031775863

Endosseous Dental Implant Abutments; affected UDIs include various lot suffixes GNNA2, JZYZ3, KRJA6, GJXT4, JLLP9, KCKL1, KPRE4, and LWZM6.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96726
Status: Active
Manufacturer: Straumann USA LLC
Sold By: Authorized dental supply distributors; Dental clinics; Specialized surgical centers
Manufactured In: United States
Units Affected: 1,786 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.