Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotom...
FDA Recall #Z-0371-2024 — Class II — October 9, 2023
Product Description
Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178402
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 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
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.