The Recall Desk
ModerateFDA (Devices)·Z-0379-2024·Announced 2023-11-29

Compress Device Short Anchor Plug recalled for potential metal burrs

Biomet recalls Compress Device Short Anchor Plug devices due to potential metal burrs in transverse holes that may prevent proper drill and pin placement during orthopedic surgery, affecting units distributed worldwide.

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 FDA Class II recall involves a confirmed manufacturing defect in a surgical implant. No injuries, hospitalizations, or illnesses have been reported. The consequence is surgical extension and corrective intervention, not patient harm, making this a moderate-severity quality issue.

Plain-English summary

Biomet, Inc. is recalling the Compress Device Short Anchor Plug, 12 MM (Item Number: 178554), a medical device used in revision orthopedic surgery to correct unsuccessful osteotomy, arthrodesis, or previous joint replacement.

The device may contain metal burrs in its transverse holes, which can prevent the drill or pins from passing through during surgical placement. This manufacturing defect may result in extension of surgery.

The affected units were distributed worldwide, including the United States, Canada, Argentina, Australia, Chile, Japan, the Netherlands, and New Zealand. Multiple lot numbers are involved, identified by their UDI codes.

Healthcare providers and patients who may have received this device should contact Biomet for guidance on next steps and potential device replacement or management.

The recalled product

Product
Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
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 (16)

  • Lot Numbers/UDI 331680 (01)00880304461703(17)270726(10)331680
  • 331690 (01)00880304461703(17)270806(10)331690
  • 331700 (01)00880304461703(17)270726(10)331700
  • 331700R (01)00880304461703(17)270726(10)331700R
  • 541430 (01)00880304461703(17)271119(10)541430
  • 577340 (01)00880304461703(17)280112(10)577340
  • 577340R (01)00880304461703(17)280112(10)577340R
  • 577660 (01)00880304461703(17)270630(10)577660
  • 608640 (01)00880304461703(17)271030(10)608640
  • 671450 (01)00880304461703(17)271030(10)671450
  • 671820 (01)00880304461703(17)270830(10)671820
  • 712430 (01)00880304461703(17)271111(10)712430
  • 735640 (01)00880304461703(17)271031(10)735640
  • 735660 (01)00880304461703(17)280416(10)735660
  • 856970 (01)00880304461703(17)280212(10)856970
  • 930730 (01)00880304461703(17)271030(10)930730

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 →

Related recalls

Same manufacturer · Biomet, Inc.

See all →

Same hazard · metal burrs

See all →