Skip to content
Recall Observatory FDA recall evidence

Device product

Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400

Z-0370-2024

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-0370-2024

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 541470 (01)00880304259690(17)270629(10)541470 608490 (01)00880304259690(17)280302(10)608490 608580 (01)00880304259690(17)271030(10)608580 609140 (01)00880304259690(17)271112(10)609140 671410 (01)00880304259690(17)271030(10)671410 671650 (01)00880304259690(17)271030(10)671650 856920 (01)00880304259690(17)271030(10)856920

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