Recall Z-0565-2020 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Wright Medical Technology, Inc.
INBONE STEM, TIBIAL, TOP, Part Number 200011901
| Date | Nov 8, 2016 |
| Status | Terminated |
| Reason | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
| Root cause | Process control |
| Action | The firm initiated the recall on 11/08/2016 by letter and email to the user level. The firm requested the return of the units. |
| Quantity | 65 units |
| Distribution | US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051023 | TOPEZ TOTAL ANKLE REPLACEMENT Topez Orthopedics, Inc., Nov 15, 2005 |