Z-0759-2007

Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant)

Name: Z-0759-2007 Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant)
Creator: Medi Manufacturing Inc
Published: 2006-08-11
License: https://open.fda.gov/license/

Medi Mfg., Inc. / initiated 2006-08-11 / Terminated / root cause: manufacturing process

FDA source

Medi Manufacturing Inc began a recall of Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant) on 2006-08-11. The reason FDA records is "Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0759-2007
Status: Terminated
Initiated: 2006-08-11
Posted: 2007-04-24
Terminated: 2011-04-12
Recalling firm: Medi Mfg., Inc.
Product: Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant).
Product code: ISY Joint, Knee, External Limb Component
Reason for recall: Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications.
Root cause tag: manufacturing process
FDA 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 in commerce: 8 units
Distribution: Nationwide.
Product codes and lots: Serial numbers 22509, 24208, 2326D, 2334C, 2337F, 2339H, 2341A 2342B

Product code ISY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)