FDAMay 28, 2019device
Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Packaged dental implant healing abutments were found to contain the wrong size device.
What to do
FDA enforcement status: Terminated
Brands named
nobel biocarenobel
UPCs
07332747034462
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAintelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5...2024-09-25
- FDANobel Biocare N1 TiUltra TCC NP 3.5x13mm2022-07-25
- FDANobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R2021-12-17
- FDANPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 773872021-03-29
- FDANPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 773632021-03-29
- FDANPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 773392021-03-29
- FDANPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 773642021-03-29
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