Biomet, Inc. Recall 93323
Description: Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
Biomet, Inc. Recall 93323 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0386-2024 |
Event ID | 93323 |
Event Description | Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566 |
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: 535440 (01)00880304461642(17)270803(10)535440; 577570 (01)00880304461642(17)270726(10)577570; 577590 (01)00880304461642(17)270802(10)577590; 608770 (01)00880304461642(17)280201(10)608770; 671520 (01)00880304461642(17)280131(10)671520; 671530 (01)00880304461642(17)271026(10)671530; 671880 (01)00880304461642(17)271114(10)671880; 671880R (01)00880304461642(17)271114(10)671880R; 735750 (01)00880304461642(17)271102(10)735750; 735750R (01)00880304461642(17)271102(10)735750R; 965240 (01)00880304461642(17)280113(10)965240 |
Center Classification Date | 20231121 |
Recall Initiation Date | 20231009 |
Recalling Firm | Biomet, Inc. |
Initial Notification | Letter |
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