Device product
Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178406
Z-0373-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0373-2024
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 018050 (01)00880304259744(17)270807(10)018050; 018050R (01)00880304259744(17)270807(10)018050R; 056160 (01)00880304259744(17)270108(10)056160; 332030 (01)00880304259744(17)270702(10)332030; 332050 (01)00880304259744(17)270710(10)332050; 608510 (01)00880304259744(17)270924(10)608510; 608600 (01)00880304259744(17)271026(10)608600; 671730 (01)00880304259744(17)270831(10)671730; 752780 (01)00880304259744(17)270817(10)752780;
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