VSP Shock Module (as part of a prosthetic foot).
FDA device recall Z-1083-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Ossur North America Inc
- Reason for recall
- Flawed shock module might cause breakage causing patient to fall.
- Action taken
- Firm will be contacting customers and patients to replace the defective components. Contact will be made by mail and by phone.
- Root cause
- Other
- Status
- Terminated
- Product code
- ISH
- Quantity affected
- 37
- Distribution
- Nationwide.
- Date initiated
- 2004-06-15
- Date posted
- 2004-07-20
- Date terminated
- 2005-06-17
- Location
- Aliso Viejo, CA
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