Recall Z-0553-2019 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer Biomet, Inc.
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) c
| Date | Oct 24, 2018 |
| Status | Terminated |
| Reason | Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted |
| Root cause | Employee error |
| Action | Zimmer Biomet initiated recall by letter on 10/24/18 to distributors and hospitals advising of the problem and action to be taken-locate quarantine and return product. Complete Inventory Return Certification Form. Questions or concerns call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. |
| Quantity | 6 units |
| Distribution | US Nationwide Distribution in the states of IN, DC, MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062998 | COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) Biomet Manufacturing Corp, Jan 19, 2007 |