Class 2 Device Recall Medipro OP4

• Date Initiated by Firm: August 11, 2006
• Date Posted: April 24, 2007
• Recall Status: Terminated on April 12, 2011
• Recall Number: Z-0759-2007
• Recall Event ID: 37604
• Product Classification: external Knee Joint prosthesis - Product Code ISY
• Product: Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant).
• Code Information: Serial numbers 22509, 24208, 2326D, 2334C, 2337F, 2339H, 2341A 2342B
• FEI Number: 3000719631
• Recalling Firm/ Manufacturer: Medi Manufacturing Inc; 6481 Franz Warner Pkwy; Whitsett NC 27377-3000
• For Additional Information Contact: Nicolas Vogel; 336-449-4440
• Manufacturer Reason for Recall: Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications.
• FDA Determined 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 in Commerce: 8 units
• Distribution: Nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.