VSP Shock Module (as part of a prosthetic foot).
This recall has been terminated (originally issued July 20, 2004).
- Company
- Ossur North America Inc
- Recall Initiated
- June 15, 2004
- Posted
- July 20, 2004
- Terminated
- June 17, 2005
- Recall Number
- Z-1083-04
- Quantity
- 37
- Firm Location
- Aliso Viejo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Flawed shock module might cause breakage causing patient to fall.
Distribution
Nationwide.
Lot / Code Info
RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012.
Root Cause
Other
Action Taken
Firm will be contacting customers and patients to replace the defective components. Contact will be made by mail and by phone.