Z-1083-04

VSP Shock Module (as part of a prosthetic foot)

Name: Z-1083-04 VSP Shock Module (as part of a prosthetic foot)
Creator: Ossur North America Inc
Published: 2004-06-15
License: https://open.fda.gov/license/

Ossur Americas / initiated 2004-06-15 / Terminated

FDA source

Ossur North America Inc began a recall of VSP Shock Module (as part of a prosthetic foot) on 2004-06-15. The reason FDA records is "Flawed shock module might cause breakage causing patient to fall". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1083-04
Status: Terminated
Initiated: 2004-06-15
Posted: 2004-07-20
Terminated: 2005-06-17
Recalling firm: Ossur Americas
Product: VSP Shock Module (as part of a prosthetic foot).
Product code: ISH Component, External, Limb, Ankle/Foot
Reason for recall: Flawed shock module might cause breakage causing patient to fall.
FDA root cause: Other
Action: Firm will be contacting customers and patients to replace the defective components. Contact will be made by mail and by phone.
Quantity in commerce: 37
Distribution: Nationwide.
Product codes and lots: RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012.

Product code ISH

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)