The Recall Desk
HighFDA (Devices)·Z-0631-2021·Announced 2020-12-23

Biomet RingLoc+ Drill Bits Recalled for Potential Sterile Seal Breach

Biomet is recalling specific lots of RingLoc+ Quick Connect Drill Bits because a breach in the sterile seal could lead to loss of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (loss of sterility) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Biomet, Inc. is recalling specific lots of RingLoc+ Quick Connect Drill Bits, item numbers 31-323215, 31-323220, 31-323230, and 31-323240. The recall involves 7,428 units that were distributed worldwide, including in the United States, Canada, Australia, and various countries in Europe, Asia, and South America.

The recall is being conducted because specific lots of these sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to a loss of sterility of the device. The affected lots include 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, and 386840.

Healthcare providers and consumers should check their inventory for these specific item numbers and lot codes. If the devices are found, they should be removed from use and returned to Biomet, Inc. or the distributor for credit or replacement.

The recalled product

Product
RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.
Manufacturer
Biomet, Inc.
Affected units
7,428

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 16 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →