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RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Pro...

FDA Recall #Z-0631-2021 — Class II — November 25, 2020

Recall #Z-0631-2021 Date: November 25, 2020 Classification: Class II Status: Terminated

Product Description

RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.

Reason for Recall

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Recalling Firm

Biomet, Inc. — Warsaw, IN

Classification

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

Product Type

Devices

Product Quantity

7428

Distribution

Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

Code Information

Lots 492670 562350 253280 253290 253300 278210 278230 417030 608110 608150 677300 253320 267910 267920 267930 267940 267960 267970 278160 363700 363720 363740 386960 492750 507930 507940 507980 508000 232590 232610 386830 386850 386860 386870 492720 530950 386840

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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