Biomet Compress Device Anchor Plugs recalled for metal burrs in transverse holes

Plain-English summary

Biomet, Inc. is recalling Compress Device Short Anchor Plugs (Item Number 178552, 10 MM size) used in orthopedic surgical procedures. The recall affects devices distributed worldwide, including throughout the United States, Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand.

The recalled anchor plugs may contain metal burrs in the transverse holes of the device. These burrs can prevent the drill or pins from passing through as intended during surgery, potentially requiring the surgical procedure to be extended.

This device is used during surgical correction procedures including revision surgeries for unsuccessful osteotomy, arthrodesis, or previous joint replacement. The affected lot numbers are listed in the recall notice.

Healthcare facilities using this device should identify affected inventory by checking the lot numbers provided in the recall. Users should contact Biomet, Inc. or the FDA for information on replacement devices or instructions for proper handling of affected units.

The recalled product

Product

Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552

Manufacturer

Biomet, Inc.

Category

Medical Device — Orthopedic Surgical

Hazard

• metal-burr
• surgical-obstruction

Is your product affected?

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

Distribution

Distributed nationwide across the United States.

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