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Terminated

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

FDA Recall Z-0185-2013 · Posted 2012-10-31

Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeLPH
Date Initiated2012-09-05
Date Terminated2014-01-07
Product Quantity840 units

Reason for Recall

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

Firm Action

Wright sent an Urgent Product Recall Notification letter dated September 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product and immediately return to Wright Medical Technology, Inc. Customers were asked to complete and return the enclosed notification form by fax to 901-867-7401. For questions customers should call 901-867-4324. For questions regarding this recall call 901-867-4655.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, The Netherlands, Argentina, Brazil, Chile, China, Japan, Taiwan, Turkey, United Arab Emirates, Australia, South Africa, Russia, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111698PROFEMUR(R) E CEMENTLESS HIP STEMWrightmedicaltechnologyinc · 2011-08-19K092201ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASEWrightmedicaltechnologyinc · 2009-08-20K052915PROFEMUR XTR HIP STEMWrightmedicaltechnologyinc · 2006-01-27K043073PROCOTYL-E ACETABULAR SYSTEMWrightmedicaltechnologyinc · 2005-05-04K021346STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XXWrightmedicaltechnologyinc · 2002-07-02K003016PRO-FEMUR RWrightmedicaltechnologyinc · 2000-12-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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