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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

DDS Lab: Dental Implant Abutments Recalled Due to Potential for Fracture and Aspiration

Agency Publication Date: February 5, 2025
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Summary

DDS Lab has issued a recall for approximately 11,259 Temporary Titanium Abutments used in definitive dental implant restoration cases. These products were mistakenly used in place of permanent abutments, which can lead to the titanium component fracturing or the dental restoration becoming loose. These affected cases were processed between August 2017 and November 2022. Because this is a medical device, consumers should contact their healthcare provider or dental professional for an evaluation of their restoration, or contact the manufacturer directly for more information.

Risk

If the temporary abutment breaks, the attached dental restoration (such as a crown) may come loose or fall out. Broken fragments or the restoration itself could cause injury to the lining of the mouth, or in more serious cases, could be accidentally swallowed or inhaled into the lungs.

What You Should Do

  1. Contact your dentist or oral surgeon to determine if your dental implant restoration involved Case IDs processed between August 2017 and November 2022.
  2. Specific Case IDs affected include a wide range of eight-digit numbers starting with 5 or 6 (such as 60772314, 50706089, and many others listed in the official recall notice).
  3. If you experience any loosening, discomfort, or breakage in your dental implant area, seek medical or dental attention immediately.
  4. Contact DDS Lab at their Tampa, Florida location or visit their website for further instructions regarding affected restorations.
  5. You can contact the FDA for additional information or to report any adverse events at 1-888-463-6332 or online at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare professional or manufacturer contact

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Temporary Titanium Abutments
Model / REF:
Z-1111-2025
Lot Numbers (984):
60772314
60822385
60812506
60246730
60342214
60325436
60239491
60000163
60000228
60000253
60000263
60000271
60000295
60000314
60000335
60000341
60000357
60000362
60000365
60000366
60000388
60000398
60000503
60000525
60000529
60000551
60000581
60000582
60000583
60000610
60000616
60000631
60000633
60000646
60000670
60000697
60000700
60000707
60000717
60000718
60000723
60000745
60000749
60000760
60000787
60000798
60000802
60000807
60000808
60000811
Date Ranges: August 2017 - November 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96064
Status: Active
Manufacturer: DDS Lab
Sold By: Dental clinics; Oral surgeons; Laboratories
Manufactured In: United States
Units Affected: 11,259
Distributed To: Florida, Tennessee, Texas, Massachusetts, New Hampshire, Connecticut, Maine, Washington, Indiana, California, Pennsylvania, Nevada, Missouri, Illinois, Alaska, Minnesota, Vermont, Ohio, Michigan, Virginia, Wisconsin, Alabama, Arizona, Kentucky, Montana, Oklahoma, Colorado, Louisiana, Georgia, New York, West Virginia, North Carolina, New Jersey, Maryland, Oregon, Delaware, South Carolina, Idaho, Kansas, Iowa, Arkansas, New Mexico, Hawaii, District of Columbia, Mississippi, Nebraska, Rhode Island, Utah

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.