Device product
Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560
Z-0382-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0382-2024
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: 331780 (01)00880304461680(17)270709(10)331780; 331790 (01)00880304461680(17)270726(10)331790; 331810 (01)00880304461680(17)270703(10)331810; 507020 (01)00880304461680(17)270724(10)507020; 507020R (01)00880304461680(17)270724(10)507020R; 608550 (01)00880304461680(17)271103(10)608550; 608700 (01)00880304461680(17)271030(10)608700; 671490 (01)00880304461680(17)271117(10)671490; 671850 (01)00880304461680(17)271102(10)671850; 857020 (01)00880304461680(17)271117(10)857020
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