Medical device recalls Moderate risk

Straumann Manufacturing, Inc. recalls Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510

Recall date
July 14, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2534-2016
FDA classification
Class II
Brand / firm
Straumann Manufacturing, Inc.
Sold / distributed
Nationwide Distribution.

Why it was recalled

Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration

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

What was recalled

Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510

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