Recall Z-0445-2007 ยท ISH Component, External, Limb, Ankle/Foot
Southern Prosthetic Supply Co.
SPS Blue Line Tube Clamp Adapters, Product No. BL120M
| Date | Jan 10, 2007 (initiated Oct 3, 2006) |
| Status | Terminated |
| Reason | Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail |
| Root cause | Other |
| Action | On October 6, 2006, SPS faxed a recall notification to the 187 customers who had purchased one or more BL120M Tube Clamp Adapters from SPS between August 29 and September 20, 2006. On October 9, SPS contacted those customers that had purchased five or more Adapters via telephone to confirm they had received the faxed recall notification. On October 10, SPS mailed another copy of the recall notification, via certified mail, return receipt requested to all of its customers that had purchased one or more BL120M Tube Clamp Adapters. The customers were told to send the BL120M Adapter back to SPS fo |
| Quantity | 943 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.