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Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm ...

FDA Recall #Z-0884-2020 — Class II — December 11, 2019

Recall #Z-0884-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

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.

Recalling Firm

Brasseler USA I Lp — Savannah, GA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

56 packs of 6

Distribution

US: AZ, AR, FL

Code Information

Lot Number NR8ZR

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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