Recall Z-0563-2020 ยท HWC Screw, Fixation, Bone
Wright Medical Technology, Inc.
ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
| 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 | 40 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
| K102429 | ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW Wrightmedicaltechnologyinc, Nov 23, 2010 |