Recall Z-0564-2020 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Wright Medical Technology, Inc.
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
| 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 | 19 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
| K083270 | WMT COMPOSITE DBM Wrightmedicaltechnologyinc, Aug 27, 2009 |