Recall Z-0196-2019 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Medacta Usa Inc
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
| Date | Nov 15, 2017 |
| Status | Terminated |
| Reason | Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem. |
| Root cause | Package design/selection |
| Action | The firm initiated the recall by telephone to its distributors. The firm requested return of all recalled units. |
| Quantity | 837 units |
| Distribution | NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170845 | MiniMAX Medacta International S.A., Aug 8, 2017 |