Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
Enforcement
- Recall Number
- Z-0379-2024
- Event ID
- 93323
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 29, 2023
- Initiation Date
- October 9, 2023
- Classification Date
- November 21, 2023
- Address
- 56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States
Description
Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
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
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;
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
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