FDA Device recall Z-1111-2025
Temporary Titanium Abutments
- FDA Device
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of Temporary Titanium Abutments by Dds Lab, citing certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the tita….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1111-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-06 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Dds Lab |
| Distribution | US |
Product
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.
Identifiers
| code_info | Dental implant restoration cases processed between August 2017 and November 2022: Case ID: 60772314 60822385 60812506…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1111-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.