The Recall Desk
HighFDA (Devices)·Z-0388-2024·Announced 2023-11-29

Biomet Compress Device Short Anchor Plug recalled due to metal burrs

Biomet is recalling Compress Device Short Anchor Plugs (28 MM, Item 178570) due to potential metal burrs in transverse holes that may prevent surgical instruments from passing through, extending surgery duration.

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: This is a FDA Class II medical device with a potential functional defect (metal burrs preventing instrument passage) that could complicate surgical procedures. While the device poses a risk of harm in the surgical setting, no injuries or illnesses have been reported in the source material.

Plain-English summary

Biomet, Inc. is recalling the Compress Device Short Anchor Plug (28 MM, Item Number 178570) due to the presence of metal burrs in the transverse holes of the device. These burrs may prevent the drill or pins from passing through during surgical procedures, potentially extending the duration of surgery.

This device is used for correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement procedures. The affected products have the following lot numbers: 178570, 535460R, and 671550, with specific UDI codes provided by the manufacturer.

The recall affects devices distributed worldwide, including the United States and internationally to Argentina, Australia, Canada, Chile, Japan, Netherlands, and New Zealand.

Patients and healthcare providers in possession of affected devices should contact Biomet, Inc. for further instructions regarding device replacement or alternative surgical options.

The recalled product

Product
Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Surgical Device
Hazard
  • metal-burrs
  • device-defect

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 (3)

  • Lot Numbers/UDI: 178570 (01)00880304461697(17)270811(10)535460
  • 535460R (01)00880304461697(17)270811(10)535460R
  • 671550 (01)00880304461697(17)271124(10)671550

Distribution

Distributed nationwide across the United States.

Related recalls

Same category