Device product
Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178408
Z-0374-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0374-2024
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: 017910 (01)00880304259768(17)270807(10)017910; 017910R (01)00880304259768(17)270807(10)017910R; 018060 (01)00880304259768(17)270817(10)018060; 332060 (01)00880304259768(17)270817(10)332060; 608610 (01)00880304259768(17)271204(10)608610; 671740 (01)00880304259768(17)271117(10)671740; 671740R (01)00880304259768(17)271117(10)671740R; 752790 (01)00880304259768(17)270816(10)752790; 752790R (01)00880304259768(17)270816(10)752790R; 965290 (01)00880304259768(17)271030(10)965290;
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