Device product
Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558
Z-0381-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0381-2024
Official wording
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
Code information: Lot Numbers/UDI: 331750 (01)00880304461673(17)270726(10)331750; 331760 (01)00880304461673(17)270725(10)331760; 331770 (01)00880304461673(17)270901(10)331770; 577380 (01)00880304461673(17)270725(10)577380; 608690 (01)00880304461673(17)271030(10)608690; 671340 (01)00880304461673(17)271026(10)671340; 671350 (01)00880304461673(17)271127(10)671350; 671460 (01)00880304461673(17)271030(10)671460; 671840 (01)00880304461673(17)271117(10)671840; 735690 (01)00880304461673(17)271030(10)735690; 735720 (01)00880304461673(17)271109(10)735720; 735720R (01)00880304461673(17)271109(10)735720R; 930750 (01)00880304461673(17)270726(10)930750
Distribution pattern: Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
Derived failure modes
-
Unknown
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