Biomet, Inc. Recall 93323
Description: Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570
Biomet, Inc. Recall 93323 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0388-2024 |
Event ID | 93323 |
Event Description | Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570 |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND. |
Quantity | N/A |
Recall 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 |
Device Classification | 20231129 |
Device Code Info | Lot Numbers/UDI: 178570 (01)00880304461697(17)270811(10)535460; 535460R (01)00880304461697(17)270811(10)535460R; 671550 (01)00880304461697(17)271124(10)671550 |
Center Classification Date | 20231121 |
Recall Initiation Date | 20231009 |
Recalling Firm | Biomet, Inc. |
Initial Notification | Letter |
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