Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0379-2024

October 09, 2023

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 93323
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0379-2024

Official wording

Reason: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Code information: 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 pattern: Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery