Device product
Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564
Z-0384-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0384-2024
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: 441020 (01)00880304461628(17)270915(10)441020; 535430 (01)00880304461628(17)270701(10)535430; 577560 (01)00880304461628(17)270725(10)577560; 577740 (01)00880304461628(17)271114(10)577740; 608760 (01)00880304461628(17)271112(10)608760; 671870 (01)00880304461628(17)280131(10)671870; 975160 (01)00880304461628(17)270806(10)975160
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