FDA Medical Device Recalls (openFDA)
Medi Manufacturing Inc: Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant).
- Recall number
- Z-0759-2007
- Recalling firm
- Medi Manufacturing Inc
- Product
- Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant).
- Status
- Terminated
- Initiated
- 2006-08-11
- Posted
- 2007-04-24
- Terminated
- 2011-04-12
- 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.
- Lot, serial or model codes
- Serial numbers 22509, 24208, 2326D, 2334C, 2337F, 2339H, 2341A 2342B
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISY
- Firm FEI
- 3000719631
- Firm city
- Whitsett
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28