RecallRadar

FDA Device recall Z-1818-2017

Keystone Dental Inc

On 2017-04-19 the FDA classified a Class II recall of Keystone Dental Inc by Keystone Dental, citing straight PrimaConnex Implants contained Tapered PrimaConnex Implants.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1818-2017
ClassificationClass II
Statusterminated
Initiated2017-03-09
Published2017-04-19
Last updated2026-09-13 11:54 UTC
CompanyKeystone Dental
DistributionCA, FL, IL, IN, MA, MN, NJ, NV, PA

Product

Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K

Reason

Straight PrimaConnex Implants contained Tapered PrimaConnex Implants

Identifiers

code_infoLot Number: 30214

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1818-2017%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.