Temporary Titanium Abutments

FDA device recall Z-1111-2025 · posted 2025-02-05 · Open, Classified

Recall details

Recalling firm

DDS Lab

Reason for recall

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.

Action taken

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 ddslab6193@sedgwick.com.

Root cause

Component design/selection

Status

Open, Classified

Product code

NHA

Quantity affected

11,259

Distribution

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

Date initiated

2024-12-06

Date posted

2025-02-05

Location

Tampa, FL

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