Z-0378-2024 Class II Ongoing

Recalled by Biomet, Inc. — Warsaw, IN

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, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552

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 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;