ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-0140, DIAMETER 11mm, LENGTH 140mm, 1 EACH, STERILE R, (FOR USE WITH CEMENT ONLY), SINGLE USE ONLY, (Ti6A14V), Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
This recall has been terminated (originally issued December 8, 2009).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- September 22, 2009
- Posted
- December 8, 2009
- Terminated
- December 16, 2010
- Recall Number
- Z-0492-2010
- Quantity
- 37 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an area with less strength. For those instances where the product has been implanted, there is the potential increased risk of failure for these patients.
Distribution
Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, and Greece
Lot / Code Info
Lot numbers: 098705608 and 098705609
Root Cause
Process control
Action Taken
Wright Medical initiated the recall of the product on September 22, 2009 by contacting the distributors by telephone followed with letters addressed to the hospitals and surgeons dated October 9, 2009. At the firm, Customer Service is the contact for return instructions and replacement inventory. This phone number is 800-238-7117. Other questions regarding this matter are directed to 800-874-5630.