SPS Blue Line Tube Clamp Adapters, Product No. BL120M
FDA Recall Z-0445-2007 · Posted 2007-01-10
Recalling FirmSouthern Prosthetic Supply Co.
Recall StatusTerminated
Product CodeISH
Date Initiated2006-10-03
Date Terminated2008-03-07
Product Quantity943 units
Reason for Recall
Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail
Firm 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 following replacement.
Root Cause
Other
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.