Medical device recalls Moderate risk

New Standard Device Inc recalls Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

Recall date
August 14, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1280-2022
FDA classification
Class II
Brand / firm
New Standard Device Inc
Sold / distributed
U.S.: AZ. CT, GA, OH, and VA O.U.S.: N/A

Why it was recalled

Due to manufacturing processing error, wrench causing stripping when torqueing nuts.

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

What was recalled

Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

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