Device product
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.
Z-0553-2019
Product summary
- Event
- Event 81513
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-0553-2019
Official wording
Reason: Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
Code information: Lot Number: 608740 UDI Number: (01)00880304461666(17)271113(10)608740
Distribution pattern: US Nationwide Distribution in the states of IN, DC, MD
Derived failure modes
-
Unknown
Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted