RecallRadar

FDA Device recall Z-2318-2024

9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture t…

On 2024-07-17 the FDA classified a Class II recall of 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture t… by Preat, citing due to incorrect milled titanium abutment being packaged and labeled.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2318-2024
ClassificationClass II
Statusongoing
Initiated2024-04-10
Published2024-07-17
Last updated2026-09-13 11:57 UTC
CompanyPreat
DistributionCA, MO, NV

Product

9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Reason

Due to incorrect milled titanium abutment being packaged and labeled.

Identifiers

code_infoModel Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588

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-2318-2024%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.