The Recall Desk
ModerateFDA (Devices)·Z-0370-2024·Announced 2023-11-29

Orthopedic Anchor Plugs Recalled for Metal Burrs Preventing Proper Installation

Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent drills or pins from passing through, potentially extending surgical procedures.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II device recall with a manufacturing defect (metal burrs) that may impair device function during surgery. No illnesses, injuries, or hospitalizations have been reported. The primary consequence is potential extension of surgical time rather than direct patient harm.

Plain-English summary

Biomet, Inc. is recalling the Compress Device Segmental Anchor Plug (10 MM, Item Number 178400). These devices are used in orthopedic surgery for correction of unsuccessful osteotomy, arthrodesis, or previous joint replacement procedures.

The anchor plugs may contain metal burrs in the transverse holes, which can prevent drills or pins from passing through properly. This defect may result in extension of the surgical procedure.

The recall affects seven specific lot numbers: 541470, 608490, 608580, 609140, 671410, 671650, and 856920. The affected devices have been distributed worldwide, including throughout the United States and to Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand.

The recalled product

Product
Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400
Manufacturer
Biomet, Inc.
Hazard
  • metal-burr
  • surgical-complication

Distribution

Distributed nationwide across the United States.