The Recall Desk
HighFDA (Devices)·Z-0387-2024·Announced 2023-11-29

Biomet Compress Device Short Anchor Plug recalled for metal burrs

Biomet is recalling the Compress Device Short Anchor Plug due to metal burrs in transverse holes that may prevent proper insertion of drill or pins, potentially extending surgical time. No injuries have been reported.

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 recall for a surgical device where no illnesses or injuries have been reported. The metal burr defect presents a risk of extended surgery, meeting the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Biomet, Inc. is recalling the Compress Device Short Anchor Plug, 26 MM (Item Number: 178568), an orthopedic surgical device used for correcting failed bone fusions and joint replacements during revision surgery.

The recall is due to a manufacturing defect: some units have metal burrs in the transverse holes of the device. These burrs can prevent the surgical drill or pins from passing through properly, which may result in extension of the surgical procedure.

The recalled devices were distributed worldwide, including the United States and Canada, Australia, Argentina, Chile, Japan, New Zealand, and the Netherlands. Specific lot numbers are identified in the recall notice. Healthcare facilities and surgeons should stop use of affected lots and contact Biomet for replacement instructions. No injuries or illnesses have been reported.

The recalled product

Product
Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic / Surgical
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 (9)

  • Lot Numbers/UDI: 535450 (01)00880304461611(17)270727(10)535450
  • 577600 (01)00880304461611(17)270630(10)577600
  • 577610 (01)00880304461611(17)270702(10)577610
  • 577760 (01)00880304461611(17)270629(10)577760
  • 671540 (01)00880304461611(17)271124(10)671540
  • 671890 (01)00880304461611(17)271114(10)671890
  • 671890R (01)00880304461611(17)271114(10)671890R
  • 857060 (01)00880304461611(17)280324(10)857060
  • 930770 (01)00880304461611(17)270725(10)930770

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.

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Same hazard · metal burr

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