Temporary Titanium Abutments
Recall
- Recall Number
- Z-1111-2025
- Event Number
- 96064
- Firm
- DDS Lab
- FEI Number
- 3004632064
- Product Code
- NHA
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- December 6, 2024
- Posted
- February 5, 2025
- Address
- 5440 Beaumont Center Blvd, Ste 400, Tampa, FL, 33634-5208
Description
Temporary Titanium Abutments
Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.
On 12/6/2024, correction notices were mailed to customers asking them to do the following: Patients that received a dental implant restoration processed with a temporary titanium abutment (cylinder) rather than a definitive titanium abutment should be contacted to inform them about this Correction. Dental providers should continue to monitor a restoration subject to this Correction for potential problems, consistent with their clinical standard of care for all dental implant restorations. Firm is actively collaborating with dental support organizations and dental offices to ensure patients are notified of this event. If a dental provider identifies a potential problem with a restoration subject to this Correction, please contact the firm. To use case ID to access additional information including patient names, use the following steps in the My DDS Lab Portal: 1) Access the MyDDSLab Portal (https://my.ddslab.com/Login.aspx) 2) Can't remember your office's log-in or password? Call 877-966-9931 to request a reset. 3) Once logged into the portal, navigate to the "Case Management" tab. 4) Search by Case ID to find the patient's name and additional details about the fabrication. 5) Once in the case, you can also choose to download the invoice that will have more specific information about the fabrication. Please direct any inquiries to the vendor supporting the market correction effort via phone at 855-544-4821 Monday thru Friday 8am to 7pm ET or by email at [email protected].
US Nationwide distribution including in the states of FL, TN, TX, MA, NH, CT, ME, WA, IN, CA, PA, NV, MO, IL, AK, MN, VT, OH, MI, VA, WI, AL, AZ, KY, MT, OK, CO, LA, GA, NY, WV, NC, NJ, MD, OR, DE, SC, ID, KS, IA, AR, NM, HI, DC, MS, NE, RI, UT.
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