Z-0379-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- October 9, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
Reason for Recall
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
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
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;