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Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying cont...

FDA Recall #Z-1629-2014 — Class II — December 3, 2013

Recall #Z-1629-2014 Date: December 3, 2013 Classification: Class II Status: Terminated

Product Description

Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.

Reason for Recall

The Irrigation Clips were assembled with the incorrect (smaller) clips.

Recalling Firm

The Anspach Effort, Inc. — Palm Beach Gardens, FL

Classification

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

Product Type

Devices

Product Quantity

150

Distribution

US Nationwide Distribution in the state of Mississippi.

Code Information

Batch G323082757.

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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