Recall Z-0493-2010 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Wright Medical Technology Inc
ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-2140, DIAMETER 13mm, 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
| Date | Dec 8, 2009 (initiated Sep 22, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 25 units |
| Distribution | Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, and Greece |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061223 | ADVANCE TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc, Aug 18, 2006 |