Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant).
FDA Recall Z-0759-2007 · Posted 2007-04-24
Recalling FirmMedi Manufacturing Inc
Recall StatusTerminated
Product CodeISY
Date Initiated2006-08-11
Date Terminated2011-04-12
Product Quantity8 units
Reason for Recall
Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.