Device product
Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568
Z-0387-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0387-2024
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: 535450 (01)00880304461611(17)270727(10)535450; 577600 (01)00880304461611(17)270630(10)577600; 577610 (01)00880304461611(17)270702(10)577610; 577760 (01)00880304461611(17)270629(10)577760; 671540 (01)00880304461611(17)271124(10)671540; 671890 (01)00880304461611(17)271114(10)671890; 671890R (01)00880304461611(17)271114(10)671890R; 857060 (01)00880304461611(17)280324(10)857060; 930770 (01)00880304461611(17)270725(10)930770
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