ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-2140, DIAMETER 13mm, LENGTH 140mm, 1 EACH, STERILE R, (FOR USE WITH
FDA device recall Z-0493-2010 · posted 2009-12-08 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MBH
- Quantity affected
- 25 units
- Distribution
- Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, and Greece
- Date initiated
- 2009-09-22
- Date posted
- 2009-12-08
- Date terminated
- 2010-12-16
- Location
- Arlington, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCE TOTAL KNEE SYSTEM (K061223) | Wrightmedicaltechnologyinc | 2006-08-18 |