Medical device recalls Moderate risk

Brasseler USA I Lp recalls Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinman…

Recall date
December 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0884-2020
FDA classification
Class II
Brand / firm
Brasseler USA I Lp
Sold / distributed
US: AZ, AR, FL

Why it was recalled

103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.

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

What was recalled

Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.

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