Device product
Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178402
Z-0371-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0371-2024
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 240750 (01)00880304259713(17)270112(10)240750 671330 (01)00880304259713(17)271114(10)671330 671420 (01)00880304259713(17)270831(10)671420 671660 (01)00880304259713(17)270901(10)671660 752730 (01)00880304259713(17)270802(10)752730 752760 (01)00880304259713(17)270816(10)752760 798010 (01)00880304259713(17)270120(10)798010 921660 (01)00880304259713(17)270724(10)921660 930670 (01)00880304259713(17)270727(10)930670 930680 (01)00880304259713(17)270802(10)930680 965330 (01)00880304259713(17)271112(10)965330
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