The Recall Desk
ModerateFDA (Devices)·Z-0380-2024·Announced 2023-11-29

Compress Device Short Anchor Plugs recalled due to metal burrs

Biomet is recalling Compress Device Short Anchor Plugs (14 MM) due to potential metal burrs in transverse holes that may prevent proper insertion during surgery. The defect may extend surgical time.

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: FDA Class II recall with a manufacturing defect (metal burrs) that may impede surgical device function. No injuries, hospitalizations, or deaths reported. The hazard is procedural inconvenience rather than direct patient harm, meeting criteria for Moderate severity.

Plain-English summary

Biomet, Inc. is recalling Compress Device Short Anchor Plugs, 14 MM (Item Number 178556), surgical anchors used for correction and revision of osteotomy, arthrodesis, and previous joint replacements.

The devices may contain metal burrs in their transverse holes, preventing surgical drill bits or pins from passing through as intended. This may result in extension of the surgical procedure.

The recall affects devices distributed worldwide, including throughout the United States and to Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand. Specific affected lot numbers have been identified by the manufacturer.

Affected individuals and healthcare facilities should contact Biomet regarding device management and replacement options.

The recalled product

Product
Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard

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 (14)

  • Lot Numbers/UDI: 331710 (01)00880304461635(17)270702(10)331710
  • 331720 (01)00880304461635(17)270723(10)331720
  • 331730 (01)00880304461635(17)270629(10)331730
  • 331740 (01)00880304461635(17)270726(10)331740
  • 477990 (01)00880304461635(17)270820(10)477990
  • 541450 (01)00880304461635(17)270725(10)541450
  • 577360 (01)00880304461635(17)270801(10)577360
  • 577690 (01)00880304461635(17)270814(10)577690
  • 577700 (01)00880304461635(17)270725(10)577700
  • 608540 (01)00880304461635(17)270902(10)608540
  • 608650 (01)00880304461635(17)271030(10)608650
  • 608670 (01)00880304461635(17)271030(10)608670
  • 671830 (01)00880304461635(17)270901(10)671830
  • 829350 (01)00880304461635(17)270823(10)829350

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

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