RecallRadar

FDA Device recall Z-2250-2020

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended…

On 2020-06-10 the FDA classified a Class II recall of Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended… by Nobel Biocare Usa, citing packaged dental implant healing abutments were found to contain the wrong size device.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2250-2020
ClassificationClass II
Statusterminated
Initiated2019-05-28
Published2020-06-10
Last updated2026-09-13 11:55 UTC
CompanyNobel Biocare Usa
DistributionUS

Product

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 temporary component to an endosseous implant to allow healing of the soft tissue.

Reason

Packaged dental implant healing abutments were found to contain the wrong size device.

Identifiers

code_infoLot 13076845

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2250-2020%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.