Recall Z-0185-2013— Wright Medical Technology Inc

Name: FDA recall Z-0185-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-05

Class II · Terminated

Class II FDA medical device recall by Wright Medical Technology Inc, initiated 2012-09-05, terminated 2014-01-07. It names 6 FDA 510(k) clearances: K111698, K092201, K052915 and 3 more. Product: Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005 Orthopaedic. Reason: There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility..

Recalling firm: Wright Medical Technology Inc
Classification: Class II
Status: Terminated
Initiated: 2012-09-05
Terminated: 2014-01-07
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

6 on FDA's record

K111698 — PROFEMUR(R) E CEMENTLESS HIP STEMWrightmedicaltechnologyinc·cleared 2011-08-19
K092201 — ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASEWrightmedicaltechnologyinc·cleared 2009-08-20
K052915 — PROFEMUR XTR HIP STEMWrightmedicaltechnologyinc·cleared 2006-01-27
K043073 — PROCOTYL-E ACETABULAR SYSTEMWrightmedicaltechnologyinc·cleared 2005-05-04
K021346 — STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XXWrightmedicaltechnologyinc·cleared 2002-07-02
K003016 — PRO-FEMUR RWrightmedicaltechnologyinc·cleared 2000-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005 Orthopaedic

Reason for recall

There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

Data sourced from openFDA. This site is unofficial and independent of the FDA.