Temporary Titanium Abutments
type: Dataset
description: FDA recall Z-1111-2025 — DDS Lab is recalling Temporary Titanium Abutments (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: Temporary Titanium Abutments
  type: MedicalDevice
  manufacturer: DDS Lab
claims: FDA recall Z-1111-2025: DDS Lab is recalling Temporary Titanium Abutments
claims: FDA classified recall Z-1111-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1111-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1111-2025
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: DDS Lab
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-12-06
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 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 6…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: 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.
      status: recorded

FDA recall Z-1111-2025: DDS Lab is recalling Temporary Titanium Abutments
type: Claim
text: The FDA logged enforcement record Z-1111-2025: DDS Lab is voluntarily recalling Temporary Titanium Abutments — reason: 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-06. Affected lots/codes: 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…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-1111-2025 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.