Device product

Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556

Z-0380-2024

October 09, 2023

Class II

Product summary

Firm: Biomet, Inc.
Event: Event 93323
Status: Ongoing
Classification: Class II
Quantity: N/A
Official record key: device-enforcement:Z-0380-2024

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: 331710 (01)00880304461635(17)270702(10)331710; 331720 (01)00880304461635(17)270723(10)331720; 331730 (01)00880304461635(17)270629(10)331730; 331740 (01)00880304461635(17)270726(10)331740; 477990 (01)00880304461635(17)270820(10)477990; 541450 (01)00880304461635(17)270725(10)541450; 577360 (01)00880304461635(17)270801(10)577360; 577690 (01)00880304461635(17)270814(10)577690; 577700 (01)00880304461635(17)270725(10)577700; 608540 (01)00880304461635(17)270902(10)608540; 608650 (01)00880304461635(17)271030(10)608650; 608670 (01)00880304461635(17)271030(10)608670; 671830 (01)00880304461635(17)270901(10)671830; 829350 (01)00880304461635(17)270823(10)829350

Distribution pattern: Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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