—#85739

Product

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

FDA product code: MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K061223
Affected lot / code info: Lot numbers: 098705608 and 098705609

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 5677 Airline Rd, Arlington, Tennessee 38002

Distribution

Distribution pattern: Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, and Greece

Timeline

Recall initiated: 2009-09-22
Posted by FDA: 2009-12-08
Terminated: 2010-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85739. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.