Medical device recalls Moderate risk

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

Recall date
March 9, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1818-2017
FDA classification
Class II
Brand / firm
Keystone Dental Inc
Sold / distributed
CA, IL, IN, FL, MA, MN, NJ, NV, PA,

Why it was recalled

Straight PrimaConnex Implants contained Tapered PrimaConnex Implants

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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