Z-0445-2007

SPS Blue Line Tube Clamp Adapters, Product No. BL120M

Name: Z-0445-2007 SPS Blue Line Tube Clamp Adapters, Product No. BL120M
Creator: Southern Prosthetic Supply Co.
Published: 2006-10-03
License: https://open.fda.gov/license/

Southern Prosthetic Supply Co. / initiated 2006-10-03 / Terminated / root cause: design

FDA source

Southern Prosthetic Supply Co. began a recall of SPS Blue Line Tube Clamp Adapters, Product No. BL120M on 2006-10-03. The reason FDA records is "Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0445-2007
Status: Terminated
Initiated: 2006-10-03
Posted: 2007-01-10
Terminated: 2008-03-07
Recalling firm: Southern Prosthetic Supply Co.
Product: SPS Blue Line Tube Clamp Adapters, Product No. BL120M
Product code: ISH Component, External, Limb, Ankle/Foot
Reason for recall: Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail
Root cause tag: design
FDA 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 following replacement.
Quantity in commerce: 943 units
Distribution: Nationwide
Product codes and lots: Product number BL120M, with the letters, ''SPS'' etched into the product

Product code ISH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)