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Recall Observatory FDA recall evidence

Device product

Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565

Z-0385-2024

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-0385-2024

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: 930790 (01)00880304528697(17)270709(10)930790

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