FDAFDA · Food and drugs·Recall number Z-0375-2024
Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
Published November 29, 2023 · Recall initiated: October 9, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
- Lot
- Lot Numbers/UDI 332070 (01)00880304259782(17)270812(10)332070; 608620 (01)00880304259782(17)271113(10)608620; 671750 (01)00880304259782(17)271115(10)671750; 752800 (01)00880304259782(17)270816(10)752800; 856930 (01)00880304259782(17)271030(10)856930; 856930R (01)00880304259782(17)271030(10)856930R; 930690 (01)00880304259782(17)270630(10)930690;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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