Device product
Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178562
Z-0383-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0383-2024
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: 331820 (01)00880304461666(17)270710(10)331820; 478000 (01)00880304461666(17)270629(10)478000; 535420 (01)00880304461666(17)270826(10)535420; 608710 (01)00880304461666(17)271114(10)608710; 608740 (01)00880304461666(17)271113(10)608740; 671500 (01)00880304461666(17)271030(10)671500; 671510 (01)00880304461666(17)280121(10)671510; 857040 (01)00880304461666(17)271112(10)857040;
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