Device product
Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
Z-0375-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0375-2024
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 332070 (01)00880304259782(17)270812(10)332070; 608620 (01)00880304259782(17)271113(10)608620; 671750 (01)00880304259782(17)271115(10)671750; 752800 (01)00880304259782(17)270816(10)752800; 856930 (01)00880304259782(17)271030(10)856930; 856930R (01)00880304259782(17)271030(10)856930R; 930690 (01)00880304259782(17)270630(10)930690;
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