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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

Product Description NexGen® Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R ;CR-FLEX GSF PCT SZ E-L MINUS ;CR-FLEX GSF PCT SZ E-R MINUS ;CR-FLEX GSF PRECOAT SZ F-L ;CR-FLEX GSF PRECOAT SZ F-R ;CR-FLEX GSF PCT SZ F-L MINUS ;CR-FLEX GSF PCT SZ F-R MINUS ;CR-FLEX GSF PRECOAT SZ G-L ;CR-FLEX GSK PRECOAT SZ G-R ;CR-FLEX GSF PCT SZ G-L MINUS ;CR-FLEX GSF PCT SZ G-R MINUS ; LPS-FLEX GSF OPT SZ C-L ; LPS-FLEX GSF OPT SZ C-R ;LPS-FLEX GSF OPT SZ D-L ;LPS-FLEX GSF OPT SZ D-R ;LPS-FLEX GSF OPT SZ E-L ;LPS-FLEX GSF OPT SZ E-R ;LPS-FLEX GSK OPT SZ F-L ;LPS-FLEX GSF OPT SZ F-R ;LPS-FLEX GSF OPT SZ G-L ; LPS-FLEX GSF OPT SZ G-R ;CR-FLEX PCT FEM B-L; CR-FLEX PCT FEM B-R; CR-FLEX PCT FEM C-L; CR-FLEX PCT FEM C-R; CR-FLEX PCT FEM C-L MINUS; CR-FLEX PCT FEM C-R MINUS; CR-FLEX PCT FEM D-L; CR-FLEX PCT FEM D-R; CR-FLEX PCT FEM D-L MINUS; CR-FLEX PCT FEM D-R MINUS; CR-FLEX PCT FEM E-L; CR-FLEX PCT FEM E-R; CR-FLEX PCT FEM E-L MINUS; CR-FLEX PCT FEM E-R MINUS; CR-FLEX PCT FEM F-L; CR-FLEX PCT FEM F-R; CR-FLEX PCT FEM F-L MINUS; CR-FLEX PCT FEM F-R MINUS; CR-FLEX PCT FEM G-L; CR-FLEX PCT FEM G-R; CR-FLEX PCT FEM G-L MINUS; CR-FLEX PCT FEM G-R MINUS; CR-FLEX POR FEM B-L; CR-FLEX POR FEM B-R; CR-FLEX POR FEM C-L; CR-FLEX POR FEM C-R; CR-FLEX POR FEM C-L MINUS; CR-FLEX POR FEM C-R MINUS; CR-FLEX POR FEM D-L; CR-FLEX POR FEM D-R; CR-FLEX POR FEM D-L MINUS; CR-FLEX POR FEM D-R MINUS; CR-FLEX POR FEM E-L; CR-FLEX POR FEM E-R; CR-FLEX POR FEM E-L MINUS; CR-FLEX POR FEM E-R; MINUS; CR-FLEX POR FEM F-L; CR-FLEX POR FEM F-R ;CR-FLEX POR FEM F-L MINUS; CR-FLEX POR FEM F-R MINUS; CR-FLEX POR FEM G-L; CR-FLEX POR FEM G-R; CR-FLEX POR FEM G-L MINUS CR-FLEX POR FEM G-R MINUS; CR-FLEX OPT FEM B-L; CR-FLEX OPT FEM B-R; CR-FLEX OPT FEM C-L; CR-FLEX OPT FEM C-R; CR-FLEX OPT FEM C-L MINUS; CR-FLEX OPT FEM C-R MINUS; CR-FLEX OPT FEM D-L; CR-FLEX OPT FEM D-R; CR-FLEX OPT FEM D-L MINUS; CR-FLEX OPT FEM D-R MINUS; CR-FLEX OPT FEM E-L; CR-FLEX OPT FEM E-R; CR-FLEX OPT FEM E-L MINUS; CR-FLEX OPT FEM E-R MINUS; CR-FLEX OPT FEM F-L; CR-FLEX OPT FEM F-R; CR-FLEX OPT FEM F-L MINUS; CR-FLEX OPT FEM F-R MINUS; CR-FLEX OPT FEM G-L; CR-FLEX OPT FEM G-R; CR-FLEX OPT FEM G-L MINUS; CR-FLEX OPT FEM G-R MINUS; LPS-FLEX CO-NID FEM A-L ; LPS-FLEX CO-NID FEM A-R ; LPS-FLEX RECOAT FEMORAL A-L; LPS-FLEX PRECOAT FEMORAL A-R; LPS-FLEX CO-NID FEM B-L ; LPS-FLEX CO-NID FEM B-R ; LPS-FLEX PRECOAT FEMORAL B-L; LPS-FLEX PRECOAT FEMORL B-R; LPS-FLEX CO-NID FEM C-L ; LPS-FLEX CO-NID FEM C-R ; LPS-FLEX PRECOAT FEMORAL C-L; LPS-FLEX PRECOAT FEMORAL C-R; LPS-FLEX CO-NID FEM D-L ; LPS-FLEX CO-NID FEM D-R ; LPS-FLEX PRECOAT FEMORAL D-L; LPS-FLEX PRECOAT FEMORAL D-R; LPS-FLEX CO-NID FEM E-L ; LPS-FLEX CO-NID FEM E-R ; LPS-FLEX PRECOAT FEMORAL E-L; LPS-FLEX PRECOAT FEMORAL E-R; LPS-FLEX CO-NID FEM F-L ; LPS-FLEX CO-NID FEM F-R ; LPS-FLEX PRECOAT FEMORAL F-L; LPS-FLEX PRECOAT FEMORAL F-R; LPS-FLEX CO-NID FEM G-L ; LPS-FLEX CO-NID FEM G-R ; LPS-FLEX PRECOAT FEMORAL G-L; LPS-FLEX PRECOAT FEMORAL G-R; LPS-FLEX PRECOAT FEMORAL H-L; LPS-FLEX PRECOAT FEMORAL H-R ; LPS-FLEX POROUS FEMORAL B-L ; LPS-FLEX POROUS FEMORAL B-R ; LPS-FLEX POROUS FEMORAL C-L ; LPS-FLEX POROUS FEMORAL C-R LPS-FLEX POROUS FEMORAL D-L ; LPS-FLEX POROUS FEMORAL D-R ; LPS-FLEX POROUS FEMORAL E-L ; LPS-FLEX POROUS FEMORAL E-R ; LPS-FLEX POROUS FEMORAL F-L ; LPS-FLEX POROUS FEMORAL F-R ;LPS-FLEX POROUS FEMORAL G-L ; LPS-FLEX POROUS FEMORAL G-R ; LPS-FLEX POROUS FEMORAL H-L ; LPS-FLEX POROUS FEMORAL H-R ; LPS-FLEX OPTION FEMORAL A-L; LPS-FLEX OPTION FEMORAL A-R; LPS-FLEX OPTION FEMORAL B-L; LPS-FLEX OPTION FEMORAL B-R; LPS-FLEX OPTION FEMORAL B-L ; LPS-FLEX OPTION FEMORAL B-R ; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTION FEMORAL D-L; LPS-FLEX OPTION FEMORAL D-R; LPS-FLEX OPTION FEMORAL D-L; LPS-FLEX OPTION FEMORAL D-R; LPS-FLEX OPTION FEMORAL E-L; LPS-FLEX OPTION FEMORAL E-R; LPS-FLEX OPTION FEMORAL E-L; LPS-FLEX OPTION FEMORAL E-R; LPS-FLEX OPTION FEMORAL F-L; LPS-FLEX OPTION FEMORAL F-R; LPS-FLEX OPTION FEMORAL F-L; LPS-FLEX OPTION FEMORAL F-R; LPS-FLEX OPTION FEMORAL G-L; LPS-FLEX OPTION FEMORAL G-R; LPS-FLEX OPTION FEMORAL G-L; LPS-FLEX OPTION FEMORAL G-R; CR OPTION FEM COMP SIZE C/L; CR OPTION FEM COMP SIZE C/R; CR OPTION FEM COMP SIZE D/L; CR OPTION FEM COMP SIZE D/R; CR OPTION FEM COMP SIZE E/L; CR OPTION FEM COMP SIZE E/R; CR OPTION FEM COMP SIZE F/L; CR OPTION FEM COMP SIZE F/R; CR OPTION FEM COMP SIZE G/L; CR OPTION FEM COMP SIZE G/R; CR PRECOAT FEM COMP SIZE AML; CR PRECOAT FEM COMP SIZE AMR; CR PRC SURF HDN FEM CO-NID AML; CR PRC SURF HDN FEM CO-NID AMR; CR PRECOAT FEM COMP SIZE BML; CR PRECOAT FEM COMP SIZE BMR; CR PRC SURF HDN FEM CO-NID BML; CR PRC SURF HDN FEM CO-NID BMR; CR PRECOAT FEM COMP SIZE C/L; CR PRECOAT FEM COMP SIZE C/R; CR PRC FEM COMP SIZE CML ; CR PRC FEM COMP SIZE CMR ; CR PRC SURF HDN FEM CO-NID C-L ; CR PRC SURF HDN FEM CO-NID C-R ; CR PRC SURF HDN FEM CO-NID CML; CR PRC SURF HDN FEM CO-NID CMR; CR PRECOAT FEM COMP SIZE D/L; CR PRECOAT FEM COMP SIZE D/R; CR PRC FEM COMP SIZE DML ; CR PRC FEM COMP SIZE DMR ; CR PRC SURF HDN FEM CO-NID D-L ; CR PRC SURF HDN FEM CO-NID D-R ; CR PRC SURF HDN FEM CO-NID DML; CR PRC SURF HDN FEM CO-NID DMR; CR PRECOAT FEM COMP SIZE E/L; CR PRECOAT FEM COMP SIZE E/R; CR PRC FEM COMP EML ;CR PRC FEM COMP SIZE EMR ; CR PRC SURF HDN FEM CO-NID E-L ; CR PRC SURF HDN FEM CO-NID E-R ; CR PRC SURF HDN FEM CO-NID EML; CR PRC SURF HDN FEM CO-NID EMR; CR PRECOAT FEM COMP SIZE F/LCR PRECOAT FEM COMP SIZE F/R; CR PRC SURF HDN FEM CO-NID F-L; CR PRC SURF HDN FEM CO-NID F-R; CR PRECOAT FEM COMP SIZE G/L; CR PRECOAT FEM COMP SIZE G/R; CR PRC SURF HDN FEM CO-NID G-L; CR PRC SURF HDN FEM CO-NID G-R; CR PRECOAT FEM COMP SIZE H/L; CR PRECOAT FEM COMP SIZE H/R; CR PRC SURF HDN FEM CO-NID H-L ; CR PRC SURF HDN FEM CO-NID H-R ; CR POROUS FEM COMP SIZE AML; CR POROUS FEM COMP SIZE AMR; CR POR SURF HDN FEM CO-NID AML; CR POR SURF HDN FEM CO-NID AMR; CR POROUS FEM COMP SIZE BML; CR POROUS FEM COMP SIZE BMR; CR POR SURF HDN FEM CO-NID BML; CR POR SURF HDN FEM CO-NID BMR; CR POROUS FEM COMP SIZE C/L; CR POROUS FEM COMP SIZE C/R; NEXGEN POROUS FEMORAL CR SIZE CM, LEFT ; NEXGEN POROUS FEMORAL CR SIZE CM, RIGHT ; CR POR SURF HDN FEM CO-NID CML; CR POR SURF HDN FEM CO-NID CMR; CR POROUS FEM COMP SIZE D/L; CR POROUS FEM COMP SIZE D/R; NEXGEN POROUS FEMORAL CR SIZE DM, LEFT; NEXGEN POROUS FEMORAL CR SIZE DM, RIGHT; CR POR SURF HDN FEM CO-NID DML; CR POR SURF HDN FEM CO-NID DMR; CR POROUS FEM COMP SIZE E/L; CR POROUS FEM COMP SIZE E/R; NEXGEN POROUS FEMORAL CR SIZE EM, LEFT; NEXGEN POROUS FEMORAL CR SIZE EM, RIGHT; CR POR SURF HDN FEM CO-NID EML; CR POR SURF HDN FEM CO-NID EMR; CR POROUS FEM COMP SIZE F/L; CR POROUS FEM COMP SIZE F/R; CR POR SURF HDN FEM CO-NID F/L; CR POR SURF HDN FEM CO-NID F/R; CR POROUS FEM COMP SIZE G/L; CR POROUS FEM COMP SIZE G/R; CR POR SURF HDN FEM CO-NID G/L; CR POR SURF HDN FEM CO-NID G/R; CR POROUS FEM COMP SIZE H/L;CR POROUS FEM COMP SIZE H/R; NEXGEN POROUS FEMORAL CR SIZE HM, LEFT; NEXGEN POROUS FEMORAL CR SIZE HM, RIGHT; NEXGEN PMMA FEMORAL LPS SIZE A, LEFT; NEXGEN PMMA FEMORAL LPS SIZE A, RIGHT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE A, LEFT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE A, LEFT ; LPS PRECOAT FEM SIZE B-LT;LPS PRECOAT FEM SIZE B-RT; LPS PRECOAT SRF HDN FEM SZ B-L; LPS PRECOAT SRF HDN FEM SZ B-R; LPS PRECOAT FEM SIZE C-LT; LPS PRECOAT FEM SIZE C-RT; LPS PRECOAT SRF HDN FEM SZ C-L; LPS PRECOAT SRF HDN FEM SZ C-R; LPS PRECOAT FEM SIZE D-LT; LPS PRECOAT FEM SIZE D-RT; LPS PRECOAT SRF HDN FEM SZ D-L; LPS PRECOAT SRF HDN FEM SZ D-R; LPS PRECOAT FEM SIZE E-LT; LPS PRECOAT FEM SIZE E-RT; LPS PRECOAT SRF HDN FEM SZ E-L; LPS PRECOAT SRF HDN FEM SZ E-R; LPS PRECOAT FEM SIZE F-LT; LPS PRECOAT FEM SIZE F-RT; LPS PRECOAT SRF HDN FEM SZ F-L; LPS PRECOAT SRF HDN FEM SZ F-R; LPS PRECOAT FEM SIZE G-LT; LPS PRECOAT FEM SIZE G-RT; LPS PRECOAT SRF HDN FEM SZ G-L; LPS PRECOAT SRF HDN FEM SZ G-R; LPS PRECOAT FEM IMPLANT SZ G-L; LPS PRECOAT FEM IMPLANT SZ G-R; NEXGEN PMMA FEMORAL LPS SIZE H, LEFT ;NEXGEN PMMA FEMORAL LPS SIZE H, RIGHT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE H, LEFT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE H, LEFT; LPS POROUS FEM SIZE B-LT; LPS POROUS FEM SIZE B-RT; LPS POROUS SRF HDN FEM SZ B-LT; LPS POROUS SRF HDN FEM SZ B-RT; LPS POROUS FEM SIZE C-LT; LPS POROUS FEM SIZE C-RT; LPS POROUS SRF HDN FEM SZ C-LT; LPS POROUS SRF HDN FEM SZ C-RT; LPS POROUS FEM SIZE D-LT; LPS POROUS FEM SIZE D-RT; LPS POROUS SRF HDN FEM SZ D-LT; LPS POROUS SRF HDN FEM SZ D-RT; LPS POROUS FEM SIZE E-LT; LPS POROUS FEM SIZE E-RT; LPS POROUS SRF HDN FEM SZ E-LT; LPS POROUS SRF HDN FEM SZ E-RT; LPS POROUS FEM SIZE F-LT; LPS POROUS FEM SIZE F-RT; LPS POROUS SRF HDN FEM SZ F-LT; LPS POROUS SRF HDN FEM SZ F-RT;LPS POROUS FEM SIZE G-LT: LPS POROUS FEM SIZE G-RT; LPS POROUS SRF HDN FEM SZ G-LT; LPS POROUS SRF HDN FEM SZ G-RT; LPS POROUS FEM IMPLANT SZ G-L; LPS POROUS FEM IMPLANT SZ G-R; LPS POROUS FEM SIZE H-LT; LPS POROUS FEM SIZE H-RT; LPS POROUS SRF HDN FEM SZ H-LT; LPS POROUS SRF HDN FEM SZ H-RT; LCCK FEM COMP SZ C-L; LCCK FEM COMP SZ C-R; LCCK FEM IMPLANT SZ C-L; LCCK FEM IMPLANT SZ C-R; LCCK FEM COMP SZ D-L; LCCK FEM COMP SZ D-R; LCCK FEM IMPLANT SZ D-L; LCCK FEM IMPLANT SZ D-R; LCCK FEM COMP SZ E-L; LCCK FEM COMP SZ E-R; LCCK FEM IMPLANT SZ E-L; LCCK FEM IMPLANT SZ E-R; LCCK FEM COMP SZ F-L; LCCK FEM COMP SZ F-R; LCCK FEM IMPLANT SZ F-L; LCCK FEM IMPLANT SZ F-R; LCCK FEM COMP SZ G-L; LCCK FEM COMP SZ G-R; LCCK FEM IMPLANT SZ G-L; LCCK FEM IMPLANT SZ G-R; LPS FEM COMP SZ A-L; LPS FEM COMP SZ A-R; LPS OPTION FEMORAL A-L; LPS OPTION FEMORAL A-R; LPS FEM COMP SZ B-L; LPS FEM COMP SZ B-R; LPS OPTION FEMORAL B-L; LPS OPTION FEMORAL B-R; LPS FEM COMP SZ C-L; LPS FEM COMP SZ C-R; LPS OPTION FEMORAL C-L; LPS OPTION FEMORAL C-R; LPS FEM COMP SZ D-L; LPS FEM COMP SZ D-R; LPS OPTION FEMORAL D-L; LPS OPTION FEMORAL D-R; LPS FEM COMP SZ E-LLPS FEM COMP SZ E-R; LPS OPTION FEMORAL E-L; LPS OPTION FEMORAL E-R; LPS FEM COMP SZ F-L; LPS FEM COMP SZ F-R; LPS OPTION FEMORAL F-L; LPS OPTION FEMORAL F-R; LPS FEM COMP SZ G-L; LPS FEM COMP SZ G-R; LPS OPTION FEMORAL G-L; LPS OPTION FEMORAL G-R; LPS FEM IMPLANT SZ G-L; LPS FEM IMPLANT SZ G-R; LPS FEM COMP SZ H-L; LPS FEM COMP SZ H-R; LPS OPTION FEMORAL H-L; LPS OPTION FEMORAL H-R; LPS FEM IMPLANT SZ H-L; LPS FEM IMPLANT SZ H-R). Provides increased flexion capability.
Recall Number Z-0073-2014
Classification Class II
Code Info Part Number Range: 005750, 5764, 5950, 5952, 5956, 5960, 5962, 5964, 5966, 5970, 5972, 5990, 5992, 5994, and 5996-011/018-01/92.
Product Distributed Qty 604064 total
Reason For Recall The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

Event Detail

Event Id 65799
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
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