Biomet Compress Device Anchor Plugs Recalled for Metal Burrs

Plain-English summary

Biomet, Inc. is recalling the Compress Device Segmental Anchor Plug, 20 MM (Item Number 178410), used in orthopedic surgery for revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. The recall was issued due to the presence of metal burrs in the transverse holes of the device, which can prevent the drill or pins from passing through properly during surgery.

This manufacturing defect may result in the extension of surgical time and complexity during the procedure. While no injuries have been reported to date, the defect creates a risk of surgical complication.

The affected devices were distributed worldwide, including throughout the United States and to Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand. Affected lot numbers include 332070, 608620, 671750, 752800, 856930, 856930R, and 930690, which can be identified through the product's UDI labeling.

Healthcare facilities and surgeons who have these devices in inventory should stop using them immediately and contact Biomet, Inc. for replacement products or further instructions. Patients who have undergone surgery with this device should consult their surgeon if they have concerns about their procedure.

The recalled product

Product

Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410

Manufacturer

Biomet, Inc.

Category

Medical Device — Orthopedic / Surgical

Hazard

• metal-burrs
• surgical-complication

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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