Device product
Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570
Z-0388-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0388-2024
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: 178570 (01)00880304461697(17)270811(10)535460; 535460R (01)00880304461697(17)270811(10)535460R; 671550 (01)00880304461697(17)271124(10)671550
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