The Recall Desk
HighFDA (Devices)·Z-0381-2024·Announced 2023-11-29

Biomet Compress Device Anchor Plugs Recalled for Metal Burrs

Biomet is recalling Compress Device Short Anchor Plugs due to metal burrs that may prevent proper surgical installation and extend operation time. Distribution includes US nationwide and eight other countries.

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: Class II medical device recall with manufacturing defect (metal burrs) that may prevent proper surgical function and extend procedure time. No reported hospitalizations or injuries, but this qualifies as a risk-of-harm product where potential complications have not yet been reported.

Plain-English summary

Biomet, Inc. is recalling Compress Device Short Anchor Plugs (16 MM, Item Number 178558) due to metal burrs in the transverse holes of the device. These burrs may prevent surgical drills or pins from passing through, potentially extending surgery time.

The affected device is used for correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. It was distributed worldwide, including the United States nationwide and Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand.

Multiple lot numbers have been identified. Healthcare providers should contact Biomet for instructions on device replacement or alternative surgical planning.

The recalled product

Product
Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic / Surgical
Hazard
  • metal-burr
  • surgical-complication
  • device-malfunction

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 (13)

  • Lot Numbers/UDI: 331750 (01)00880304461673(17)270726(10)331750
  • 331760 (01)00880304461673(17)270725(10)331760
  • 331770 (01)00880304461673(17)270901(10)331770
  • 577380 (01)00880304461673(17)270725(10)577380
  • 608690 (01)00880304461673(17)271030(10)608690
  • 671340 (01)00880304461673(17)271026(10)671340
  • 671350 (01)00880304461673(17)271127(10)671350
  • 671460 (01)00880304461673(17)271030(10)671460
  • 671840 (01)00880304461673(17)271117(10)671840
  • 735690 (01)00880304461673(17)271030(10)735690
  • 735720 (01)00880304461673(17)271109(10)735720
  • 735720R (01)00880304461673(17)271109(10)735720R
  • 930750 (01)00880304461673(17)270726(10)930750

Distribution

Distributed nationwide across the United States.

Related recalls

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