Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy...
FDA Recall #Z-0370-2024 — Class II — October 9, 2023
Product Description
Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400
Reason for Recall
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
Recalling Firm
Biomet, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
Distribution
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.