Device product
Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
Z-0386-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0386-2024
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: 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
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