Temporary Titanium Abutments
Medical device recall Z-1111-2025. Published in FDA’s Enforcement Report on Feb 12, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 12, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 48 states named
- 11,259 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Temporary Titanium Abutments
11,259, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Dental implant restoration cases processed between August 2017 and November 2022: Case ID: 60772314 60822385 60812506 60246730 60342214 60325436 60239491 60000163 60000228 60000253 60000263 60000271 60000295 60000314 60000335 60000341…
Every code shown here, 1,999 characters
Dental implant restoration cases processed between August 2017 and November 2022: Case ID: 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 60000813 60000817 60000823 60000836 60000848 60000850 60000855 60000877 60000890 60000903 60000926 60000927 60000945 60000968 60000982 60000997 60001014 60001015 60001016 60001037 60001040 60001059 60001062 60001079 60001081 60001096 60001106 60001117 60001127 60001130 60001137 60001151 60001160 60001171 60001174 60001182 60001187 60001194 60001200 60001209 60001222 60006583 60001245 60001267 60001277 60001287 60001289 60001291 60001298 60001305 60001313 60001332 60001344 60001347 60001366 60001368 60001371 60001372 60001387 60001391 60001410 60001416 60001427 60001428 60001452 60001466 60001480 60001482 60001501 60001547 60001550 60001555 60001557 60001576 60001580 60001592 60001594 60001598 60001599 60001612 60001614 60001621 60001628 60001634 60001674 60001700 60003149 60001706 60001720 60001725 60001726 60001742 60001762 60001815 60001865 60001872 60001882 60001898 60003195 60001905 60001917 60001920 60001931 60001933 60001955 60001964 60001967 60001999 60002010 60002011 60002012 60002017 60002018 60002034 60002038 60002048 60002067 60002074 60002085 60002122 60002131 60002133 60002136 60002138 60002160 60002176 60002189 60002191 60002223 60002224 60002241 60002270 60002274 60002276 60002282 60002291 60002295 60002296 60002301 60002320 60002321 60002365 60002368 60002369 60003188 60002389 60002422 60002423 60002452 60002460 60002481 60002499 60002526 60002543 60002595 60002607 60002610 60002623 60002633 60002656 60002706 60002758…
FDA’s list runs to 97,663 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
48 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 6, 2024.
- FDA classified it on Feb 5, 2025.
- FDA’s Enforcement Report published it on Feb 12, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- DDS Lab, of Tampa, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 97,663 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.