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.
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. 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, ID, KS, IA, AR, NM, HI, DC, MS, NE, RI, UT. Quantity: 11,259 Lot/code info: 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 60001
Official record: FDA (Device enforcement) ↗
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