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Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Int...

FDA Recall #Z-0735-2019 — Class II — November 28, 2018

Recall #Z-0735-2019 Date: November 28, 2018 Classification: Class II Status: Terminated

Product Description

Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

Reason for Recall

There is a potential for silicone shedding during cleaning and sterilization.

Recalling Firm

Zimmer Biomet, Inc. — Warsaw, IN

Classification

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

Product Type

Devices

Product Quantity

971 in total

Distribution

Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.

Code Information

Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512867 512868

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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