The Recall Desk
HighFDA (Devices)·Z-0373-2024·Announced 2023-11-29

Biomet Compress Device Segmental Anchor Plugs Recalled for Metal Burrs

Biomet has recalled certain Compress Device Segmental Anchor Plugs (16 MM) due to metal burrs in the transverse holes. These burrs may prevent the drill or pins from passing through, potentially extending surgical 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: FDA Class II device recall with no reported injuries or hospitalizations. The hazard—metal burrs preventing proper device insertion—creates a risk of surgical complication (extended procedure time) where the defect itself is real but no adverse events have been reported.

Plain-English summary

Biomet, Inc. is recalling certain Compress Device Segmental Anchor Plugs, 16 MM (Item Number 178406) used for correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.

The devices may contain metal burrs in the transverse holes. During surgical insertion, these burrs can prevent the drill or pins from passing through properly, which may result in extension of the surgical procedure.

The recalled devices were distributed worldwide, including throughout the US Nationwide, and internationally to Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand. Multiple lot numbers are affected, including 018050, 018050R, 056160, 332030, 332050, 608510, 608600, 671730, and 752780.

Healthcare providers and patients who have received these devices should contact Biomet for instructions regarding replacement or remediation. Patients should not discontinue use of the device without consulting their healthcare provider.

The recalled product

Product
Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178406
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Surgical Implant
Hazard
  • metal-burrs
  • device-malfunction
  • 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 (9)

  • Lot Numbers/UDI 018050 (01)00880304259744(17)270807(10)018050
  • 018050R (01)00880304259744(17)270807(10)018050R
  • 056160 (01)00880304259744(17)270108(10)056160
  • 332030 (01)00880304259744(17)270702(10)332030
  • 332050 (01)00880304259744(17)270710(10)332050
  • 608510 (01)00880304259744(17)270924(10)608510
  • 608600 (01)00880304259744(17)271026(10)608600
  • 671730 (01)00880304259744(17)270831(10)671730
  • 752780 (01)00880304259744(17)270817(10)752780

Distribution

Distributed nationwide across the United States.

Related recalls

Same category