The Recall Desk
HighFDA (Devices)·Z-0625-2021·Announced 2020-12-23

Biomet Phoenix Interlocking Screws Recalled for Potential Sterile Seal Breach

Biomet is recalling specific lots of Phoenix interlocking screws 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, fitting the High severity criteria.

Plain-English summary

Biomet, Inc. is recalling specific lots of PHOENIX interlocking screws for IM nail, item numbers 14-405040, 14-405042, 14-405044, and 14-405070. These devices are used for fracture fixation of small bones, small bone fragments, and long bones. The recall involves 7,428 units distributed worldwide, including the United States, Argentina, Australia, Brazil, Canada, Chile, China, Costa Rica, EMEA, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, and Taiwan.

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 lot numbers are 373200, 168810, 450100, 168540, and 450090.

Healthcare providers and facilities should check their inventory for these specific item numbers and lot numbers. If the devices are found, they should be removed from use and returned to Biomet, Inc. according to the recall instructions.

The recalled product

Product
PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
7,428

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot numbers 373200 168810 450100 168540 450090

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 →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · loss of sterility

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