Device product
Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404
Z-0372-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0372-2024
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 017900 (01)00880304002890(17)270912(10)017900; 017900R (01)00880304002890(17)270912(10)017900R; 240760 (01)00880304002890(17)270120(10)240760; 332020 (01)00880304002890(17)270725(10)332020; 332040 (01)00880304002890(17)270629(10)332040; 608500 (01)00880304002890(17)270830(10)608500; 608590 (01)00880304002890(17)271030(10)608590; 609150 (01)00880304002890(17)270830(10)609150; 671670 (01)00880304002890(17)271030(10)671670; 712220 (01)00880304002890(17)270114(10)712220; 752770 (01)00880304002890(17)270814(10)752770; 798020 (01)0 0880304002890(17)270120(10)798020; 965310 (01)00880304002890(17)271112(10)965310,
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