The Recall Desk
HighFDA (Devices)·Z-0376-2024·Announced 2023-11-29

Compress Device Anchor Plugs Recalled for Metal Burrs in Surgical Holes

Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs that may prevent surgical instruments from passing through properly. The defect may result in extended surgery time.

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 an FDA Class II device with a manufacturing defect (metal burrs) that poses risk during surgical use by preventing proper instrument passage. The source does not report any injuries or hospitalizations, placing this in the 'risk-of-harm' category per the rubric criteria for products where injury has not yet been reported.

Plain-English summary

Biomet, Inc. is recalling Compress Device Segmental Anchor Plugs, 22 MM (Item Number 178412), due to the presence of metal burrs in the transverse holes of the device. These burrs can prevent surgical drills or pins from passing through the device as intended.

The affected devices have been distributed worldwide, including throughout the United States and in Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand. The recalled lot numbers are: 332080, 671760, 752810, 856940, and 930700.

Surgeons and surgical centers using these devices should immediately stop using affected units and contact Biomet, Inc. for instructions on device replacement or alternatives. Patients who have already received this device as part of a surgical procedure should consult with their healthcare provider to determine if their specific device is affected.

The recalled product

Product
Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Surgical Implant
Hazard
  • metal-burrs
  • surgical-obstruction
  • 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.

Lot numbers (5)

  • Lot Numbers/UDI 332080 (01)00880304259805(17)270706(10)332080
  • 671760 (01)00880304259805(17)271026(10)671760
  • 752810 (01)00880304259805(17)270725(10)752810
  • 856940 (01)00880304259805(17)271030(10)856940
  • 930700 (01)00880304259805(17)270816(10)930700

Distribution

Distributed nationwide across the United States.

Related recalls

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