Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552
Enforcement
- Recall Number
- Z-0378-2024
- 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, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552
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 331640 (01)00880304461659(17)270726(10)331640; 331660 (01)00880304461659(17)270629(10)331660; 331670 (01)00880304461659(17)270726(10)331670; 477980 (01)00880304461659(17)280112(10)477980; 577330 (01)00880304461659(17)270725(10)577330; 577640 (01)00880304461659(17)270816(10)577640; 608520 (01)00880304461659(17)271030(10)608520; 608530 (01)00880304461659(17)280112(10)608530; 608630 (01)00880304461659(17)271204(10)608630; 671430 (01)00880304461659(17)271204(10)671430; 671810 (01)00880304461659(17)271117(10)671810; 735610 (01)00880304461659(17)271209(10)735610; 735960 (01)00880304461659(17)271202(10)735960; 795170 (01)00880304461659(17)290305(10)795170; 856960 (01)00880304461659(17)271115(10)856960; 930720 (01)00880304461659(17)270703(10)930720; 975150 (01)00880304461659(17)270731(10)975150; 982350 (01)00880304461659(17)270723(10)982350;
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
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