FDAMarch 14, 2019device
Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
What to do
FDA enforcement status: Terminated
Brands named
nobel biocarenobel
UPCs
07332747005295
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to res...2025-01-10
- 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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