Recall Z-1083-04 ยท ISH Component, External, Limb, Ankle/Foot
Ossur North America Inc
VSP Shock Module (as part of a prosthetic foot).
| Date | Jul 20, 2004 (initiated Jun 15, 2004) |
| Status | Terminated |
| Reason | Flawed shock module might cause breakage causing patient to fall. |
| 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 | 37 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.