FDAFDA · Food and drugs·Recall number Z-0553-2019
Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma. The Compress¿ Segmental Femoral Replacement System (Short Spindle and Anchor Plug) components are intended for uncemented use only.
Published December 12, 2018 · Recall initiated: October 24, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- US Nationwide Distribution in the states of IN, DC, MD
- Lot
- Lot Number: 608740 UDI Number: (01)00880304461666(17)271113(10)608740
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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