FDA Medical Device Recalls (openFDA)
Southern Prosthetic Supply Co.: SPS Blue Line Tube Clamp Adapters, Product No. BL120M
- Recall number
- Z-0445-2007
- Recalling firm
- Southern Prosthetic Supply Co.
- Product
- SPS Blue Line Tube Clamp Adapters, Product No. BL120M
- Status
- Terminated
- Initiated
- 2006-10-03
- Posted
- 2007-01-10
- Terminated
- 2008-03-07
- 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 following replacement.
- Quantity
- 943 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Product number BL120M, with the letters, ''SPS'' etched into the product
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISH
- Firm FEI
- 1043591
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28