Medical device recalls Moderate risk

Keystone Dental Inc recalls Paltop 1.25 Hex Drivers, Long Part Number: 60-70101

Recall date
February 22, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1063-2019
FDA classification
Class II
Brand / firm
Keystone Dental Inc
Sold / distributed
FL, MA, SC, VA

Why it was recalled

Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

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

What was recalled

Paltop 1.25 Hex Drivers, Long Part Number: 60-70101

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