Recall Z-0759-2007 ยท ISY Joint, Knee, External Limb Component
Medi Manufacturing Inc
Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant).
| Date | Apr 24, 2007 (initiated Aug 11, 2006) |
| Status | Terminated |
| Reason | Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications. |
| Root cause | Other |
| Action | Each consignee was contacted by phone on 8/11/2006. A follow up letter was sent to consignees on 8/11/2006 providing details on who to contact and how to return the affected devices for replacement. A self addressed, stamped response form was included to be completed and returned to Medi. |
| Quantity | 8 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.