Recall Z-0184-2013 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Wright Medical Technology Inc
Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT TIBIAL "913 PCR" T.2 - EP.10-, PGA00080, Lot Numbers: X02396582, X05401377, and W01287345 INSERT TIBIAL "913 PCR" T.3 - EP
| Date | Oct 31, 2012 (initiated Sep 5, 2012) |
| Status | Terminated |
| Reason | There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 729 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003016 | PRO-FEMUR R Wrightmedicaltechnologyinc, Dec 13, 2000 |
| K021346 | STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX Wrightmedicaltechnologyinc, Jul 2, 2002 |
| K043073 | PROCOTYL-E ACETABULAR SYSTEM Wrightmedicaltechnologyinc, May 4, 2005 |
| K052915 | PROFEMUR XTR HIP STEM Wrightmedicaltechnologyinc, Jan 27, 2006 |
| K092201 | ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE Wrightmedicaltechnologyinc, Aug 20, 2009 |
| K111698 | PROFEMUR(R) E CEMENTLESS HIP STEM Wrightmedicaltechnologyinc, Aug 19, 2011 |