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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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 Class 2 Recall
Stryker Orthopaedics
see related information
Date Posted November 13, 2012
Recall Status1 Open
Recall Number Z-0286-2013
Recall Event ID 63275
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
Product Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients who require reconstruction of large acetabular defects after a Type I and II pelvic resection.
Code Information Multiple codes C-2051-7-004 RX00138D FEMORAL PELVIC EXTENSION C-2052-5-004 RX00146D FEMORAL PELVIC EXTENSION C-HM42-7-802 RX4278C 40MM EXT W/FEMALE V40 TAPER C-HM42-7-803 RX4278D 50MM EXT W/FEMALE V40 TAPER C-HM42-7-804 RX4278E 60MM EXT W/FEMALE V40 TAPER C-HM49-4-401 RX4944B PAR 40MM EXT W/FEMALE V40 TAPE C-HM49-4-402 RX4944C PAR 50MM EXT W/FEMALE V40 TAPE C-HM49-4-403 RX4944D PAR 60MM EXT W/FEMALE V40 TAPE C-HM49-9-202 RX4992C PAR EXTENSION C-TAPER 40MM C-HM49-9-203 RX4992D PAR EXTENSION C-TAPER 50MM C-HM49-9-204 RX4992E PAR EXTENSION C-TAPER 60MM C-HM52-1-802 RX5218C PAR FEMORAL EXT V40 TAPER 40MM C-KM10-9-400 HG102AA FEMORAL PELVIC EXTENSION C-KM26-5-204 RX2652E PAR FEM EXT V-40, 40MM C-KM26-5-205 RX2652S PAR FEM EXT V-40 50MM C-KM26-5-206 RX2652T PAR FEM EXT V-40 60MM C-KM28-1-501 RX2815B PAR FEM EXT V-40, 40MM C-KM28-1-502 RX2815C PAR FEM EXT V-40 50MM C-KM28-1-503 RX2815D PAR FEM EXT V-40 60MM C-KM28-4-201 RX2842B PAR FEM EXT V-40, 40MM C-KM28-4-202 RX2842C PAR FEM EXT V-40, 50MM C-KM28-4-203 RX2842D PAR FEM EXT V-40, 60MM C-KM28-6-901 RX2869B PAR FEM EXT V-40, 40MM C-KM28-6-902 RX2869C PAR FEM EXT V-40, 50MM C-KM28-6-903 RX2869D PAR FEM EXT V-40, 60MM C-KM28-7-801 RX2878B PAR FEM EXT V-40, 40MM C-KM28-7-802 RX2878C PAR FEM EXT V-40 50MM C-KM28-7-803 RX2878D PAR FEM EXT V-40 60MM C-KM29-6-101 KM2961B PAR FEM EXT V-40, 50MM C-KM29-6-102 RX2961C PAR FEM EXT V-40, 60MM C-KM29-9-101 RX2991B PAR FEM EXT V-40, 50MM C-KM29-9-102 RX2991C PAR FEM EXT V-40 60MM C-KM30-0-901 RX3009B PAR FEM EXT V-40, 50MM C-KM30-0-902 RX3009C PAR FEM EXT V-40, 60MM C-KM30-1-101 RX3011B PAR FEM EXT V-40, 50MM C-KM30-1-102 RX3011C PAR FEM EXT V-40 60MM C-KM32-0-801 RX3208B PAR FEM EXT V-40, 50MM C-KM32-0-802 RX3208C PAR FEM EXT V-40 60MM C-KM32-9-201 RX3292B 40MM EXT W/FEMALE V40 TAPER C-KM32-9-202 RX3292C 50MM EXT W/FEMALE V40 TAPER C-KM32-9-203 RX3292D 60MM EXT W/FEMALE V40 TAPER C-KM33-6-601 RX3366B 40MM EXT W/FEMALE V40 TAPER C-KM33-6-602 RX3366C 50MM EXT W/FEMALE V40 TAPER C-KM33-6-603 RX3366D 60MM EXT W/FEMALE V40 TAPER C-KM34-8-902 RX3489C 40MM EXT W/FEMALE V40 TAPER C-KM35-4-501 RX3545B 40MM EXT W/FEMALE V40 TAPER C-KM35-4-502 RX3545C 50MM EXT W/FEMALE V40 TAPER C-KM35-4-503 RX3545D 60MM EXT W/FEMALE V40 TAPER C-KM35-5-501 RX3555B 40MM EXT W/FEMALE V40 TAPER C-KM35-5-502 RX3555C 50MM EXT W/FEMALE V40 TAPER C-KM35-5-503 RX3555D 60MM EXT W/FEMALE V40 TAPER C-KM35-9-001 RX3590B 40MM EXT W/FEMALE V40 TAPER C-KM37-5-101 RX3751B 40MM EXT W/FEMALE V40 TAPER C-KM37-5-102 RX3751C 50MM EXT W/FEMALE V40 TAPER C-KM37-5-103 RX3751D 60MM EXT W/FEMALE V40 TAPER C-KM37-7-100 RX3771A 40MM EXT W/FEMALE V40 TAPER C-KM37-7-101 RX3771B 50MM EXT W/FEMALE V40 TAPER C-KM37-7-102 RX3771C 60MM EXT W/FEMALE V40 TAPER C-KM37-7-801 RX3778B 40MM EXT W/FEMALE V40 TAPER C-KM37-7-803 RX3778D 60MM EXT W/FEMALE V40 TAPER C-KM37-8-401 RX3784B 40MM EXT W/FEMALE V40 TAPER C-KM37-8-402 RX3784C 60MM EXT W/FEMALE V40 TAPER C-KM38-1-301 RX3813B 40MM EXT W/FEMALE V40 TAPER C-KM38-1-302 RX3813C 50MM EXT W/FEMALE V40 TAPER C-KM38-1-303 RX3813D 60MM EXT W/FEMALE V40 TAPER C-KM39-1-101 RX3911B 40MM EXT W/FEMALE V40 TAPER C-KM39-1-102 RX3911C 50MM EXT W/FEMALE V40 TAPER C-KM39-1-103 RX3911D 60MM EXT W/FEMALE V40 TAPER C-KM40-1-301 RX4013B 40MM EXT W/FEMALE V40 TAPER C-KM40-1-302 RX4013C 50MM EXT W/FEMALE V40 TAPER C-KM40-1-303 RX4013D 60MM EXT W/FEMALE V40 TAPER C-KM40-6-400 RX4064A 40MM EXT W/FEMALE V40 TAPER C-KM40-7-301 RX4073B 40MM EXT W/FEMALE V40 TAPER C-KM40-7-302 RX4073C 50MM EXT W/FEMALE V40 TAPER C-KM40-9-501 RX4095B 40MM EXT W/FEMALE V40 TAPER C-KM40-9-502 RX4095C 50MM EXT W/FEMALE V40 TAPER C-KM40-9-503 RX4095D 60MM EXT W/FEMALE V40 TAPER C-KM41-3-001 RX4130B 40MM EXT W/FEMALE V40 TAPER C-KM41-3-002 RX4130C 50MM EXT W/FEMALE V40 TAPER C-KM41-3-003 RX4130D 60MM EXT W/FEMALE V40 TAPER C-KM41-6-401 RX4164B 40MM EXT W/FEMALE V40 TAPER C-KM41-6-402 RX4164C 50MM EXT W/FEMALE V40 TAPER C-KM41-6-403 RX4164D 60MM EXT W/FEMALE V40 TAPER C-KM42-7-902 RX4279C 50MM EXT W/FEMALE V40 TAPER C-KM42-7-903 RX4279D 60MM EXT W/FEMALE V40 TAPER C-KM43-0-401 RX4304B 40MM EXT W/FEMALE V40 TAPER C-KM43-0-402 RX4304C 50MM EXT W/FEMALE V40 TAPER C-KM43-0-403 RX4304D 60MM EXT W/FEMALE V40 TAPER C-KM43-1-201 RX4312B 40MM EXT W/FEMALE V40 TAPER C-KM43-1-202 RX4312C 50MM EXT W/FEMALE V40 TAPER C-KM43-1-203 RX4312D 60MM EXT W/FEMALE V40 TAPER C-KM43-1-301 RX4313B 40MM EXT W/FEMALE V40 TAPER C-KM43-1-302 RX4313C 50MM EXT W/FEMALE V40 TAPER C-KM43-1-303 RX4313D 60MM EXT W/FEMALE V40 TAPER C-KM43-2-101 RX4321B 40MM EXT W/FEMALE V40 TAPER C-KM43-4-900 RX4349A 50MM EXT W/FEMALE C-TAPER C-KM43-4-901 RX4349B 60MM EXT W/FEMALE C-TAPER C-KM43-5-901 RX4359B 40MM EXT W/FEMALE V40 TAPER C-KM43-5-902 RX4359C 50MM EXT W/FEMALE V40 TAPER C-KM43-5-903 RX4359D 60MM EXT W/FEMALE V40 TAPER C-KM43-7-901 RX4379B 40MM EXT W/FEMALE V40 TAPER C-KM43-7-902 RX4379C 50MM EXT W/FEMALE V40 TAPER C-KM43-7-903 RX4379D 60MM EXT W/FEMALE V40 TAPER C-KM43-9-501 RX4395B 40MM EXT W/FEMALE V40 TAPER C-KM43-9-502 RX4395C 50MM EXT W/FEMALE V40 TAPER C-KM43-9-503 RX4395D 60MM EXT W/FEMALE V40 TAPER C-KM44-1-701 RX4417B 40MM EXT W/FEMALE V40 TAPER C-KM44-1-702 RX4417C 50MM EXT W/FEMALE V40 TAPER C-KM44-1-703 RX4417D 60MM EXT W/FEMALE V40 TAPER C-KM44-2-701 RX4427B 40MM EXT W/FEMALE V40 TAPER C-KM44-2-702 RX4427C 50MM EXT W/FEMALE V40 TAPER C-KM44-2-703 RX4427D 60MM EXT W/FEMALE V40 TAPER C-KM45-1-801 RX4518B 40MM EXT W/FEMALE V40 TAPER C-KM45-1-802 RX4518C 50MM EXT W/FEMALE V40 TAPER C-KM45-1-803 RX4518D 60MM EXT W/FEMALE V40 TAPER C-KM46-9-301 RX4693B 40MM EXT W/FEMALE V40 TAPER C-KM50-2-202 RX5022C PAR FEM EXT C-TAPER 40MM C-KM50-2-203 RX5022D PAR FEM EXT C-TAPER 50MM C-KM50-2-204 RX5022E PAR FEM EXT C-TAPER 60MM C-KM50-4-102 RX5041C PAR 40MM EXT W/FEMALE V40 TAPE C-KM51-6-202 RX5162C PAR 40MM EXT W/FEMALE V40 TAPE C-M052-9-402 RX5294C PAR FEM EXT V40 40MM C-M053-2-202 RX5322C PAR FEM EXTENSION C-TAPER 40MM C-M053-2-203 RX5322D PAR FEM EXTENSION C-TAPER 50MM C-M053-2-204 RX5322E PAR FEM EXTENSION C-TAPER 60MM C-M054-3-202 RX5432C PAR EXTENTION 50MM V40 TAPER C-M054-3-203 RX5432D PAR EXTENSION 60MM V40 TAPER C-M054-9-902 RX5499C PAR EXTENSION V40 TAPER 40MM C-M055-2-603 RX5526D PAR FEMORAL EXTENSION V40 TAPE C-M055-2-604 RX5526E PAR FEMORAL EXTENSION V40 TAPE C-M055-3-402 RX5534C PAR FEMORAL EXT V40 TAPER 40MM C-M055-3-403 RX5534D PAR FEMORAL EXT V40 TAPER 50MM C-M055-3-404 RX5534E PAR FEMORAL EXT V40 TAPER 60MM C-M055-9-301 RX5593B TI PAR FEMORAL EXT V40 TAPER 4 C-M056-1-102 RX5611C PAR FEMORAL EXT V40 TAPER 40MM C-M056-1-103 RX5611D PAR FEMORAL EXT V40 TAPER 50MM C-M056-1-104 RX5611E PAR FEMORAL EXT V40 TAPER 60MM C-M056-4-202 RX5642C PAR FEM EXT V40 TAPER 40MM C-M056-4-203 RX5642D PAR FEM EXT V40 TAPER 50MM C-M056-4-204 RX5642E PAR FEM EXT V40 TAPER 60MM C-M059-1-202 RX05912C PAR FEM EXT V40 TAPER 40MM C-M062-2-601 RX06226B PAR FEM EXT C-TAPER 40MM C-M062-2-602 RX06226C PAR FEM EXT C-TAPER 50MM C-M062-2-603 RX06226D PAR FEM EXT C-TAPER 60MM C-M062-3-401 RX06234B PERI-ACETABULAR PROSTHESIS FEM C-M062-3-402 RX06234C PERI-ACETABULAR PROSTHESIS FEM C-M062-3-403 RX06234D PERI-ACETABULAR PROSTHESIS FEM C-M062-5-702 RX06257C PAR EXT V40 TAPER 40MM C-M062-5-703 RX06257D PAR EXT V40 TAPER 50MM C-M062-5-704 RX06257E PAR EXT V40 TAPER 60MM C-M062-8-500 RX06285A PAR FEMORAL EXT C-TAPER 60mm C-M062-9-202 RX06292C PAR FEMORAL EXT V40 TAPER 40MM C-M062-9-203 RX06292D PAR FEMORAL EXT V40 TAPER 50MM C-M062-9-204 RX06292E PAR FEMORAL EXT V40 TAPER 60MM C-M063-6-601 RX06366B PAR FEM EXT V40 TAPER 40MM C-M063-6-602 RX06366C PAR FEM EXT V40 TAPER 50MM C-M063-8-702 RX06387C PAR FEM EXT V40 TAPER 40MM C-M064-3-102 RX06431C PAR FEM EXT V40 TAPER 40MM C-M064-3-103 RX06431D PAR FEM EXT V40 TAPER 50MM C-M064-3-104 RX06431E PAR FEM EXT V40 TAPER 60MM C-M066-2-302 RX06623C PAR FEM EXT V40 TAPER 40MM C-M066-2-303 RX06623D PAR FEM EXT V40 TAPER 50MM C-M066-2-304 RX06623E PAR FEM EXT V40 TAPER 60MM C-M066-6-003 RX06660D PAR FEM EXT V40 TAPER 50MM C-M066-6-004 RX06660E PAR FEM EXT V40 TAPER 60MM C-M066-8-602 RX06686C PAR FEM EXT V40 TAPER 50MM C-M066-9-302 RX06693C PAR FEM EXT V40 TAPER 40MM C-M066-9-303 RX06693D PAR FEM EXT V40 TAPER 50MM C-M066-9-304 RX06693E PAR FEM EXT V40 TAPER 60MM C-M067-1-002 RX06710C PAR FEM EXT V40 TAPER 40MM C-M067-1-003 RX06710D PAR FEM EXT V40 TAPER 50MM C-M067-4-402 RX06744C PAR FEMORAL EXTENSION V40 TAPE C-M067-4-403 RX06744D PAR FEMORAL EXTENSION V40 TAPE C-M067-4-404 RX06744E PAR FEMORAL EXTENSION V40 TAPE C-M067-4-702 RX06747C PAR FEMORAL EXTENSION V40 TAPE C-M067-4-703 RX06747D PAR FEMORAL EXTENSION V40 TAPE C-M067-4-704 RX06747E PAR FEMORAL EXTENSION V40 TAPE C-M067-5-105 RX06571C PAR V-40 FEMORAL EXTENSION PI C-M067-5-106 RX06751D PAR V-40 FEMORAL EXTENSION PI C-M067-5-107 RX06751E PAR V-40 FEMORAL EXTENSION PI C-M068-0-902 MHM2LD PAR V-40 FEMORAL EXTENSION PI C-M068-0-903 MHM2LE PAR V-40 FEMORAL EXTENSION PI C-M068-0-904 MHM2LH PAR V-40 FEMORAL EXTENSION PI C-M068-2-402 MHM8YD PAR V40 FEMORAL EXTENSION 40MM C-M068-2-403 MHM8YE PAR V40 FEMORAL EXTENSION 50MM C-M068-6-902 MHN77T PAR V40 TAPER EXTENSION PIECE C-M068-6-903 MHN77V PAR V40 TAPER EXTENSION PIECE C-M068-6-904 MHN77W PAR V40 TAPER EXTENSION PIECE C-M068-7-402 MHN77X PAR V40 TAPER EXTENSION PIECE C-M068-7-403 MHN77Y PAR V40 TAPER EXTENSION PIECE C-M068-7-404 MHN780 PAR V40 TAPER EXTENSION PIECE C-M068-9-902 MHNYT1 PAR V40 TAPER EXTENSION PIECE C-M068-9-903 MHNYT2 PAR V40 TAPER EXTENSION PIECE C-M068-9-904 MHNYT3 PAR V40 TAPER EXTENSION PIECE C-M069-2-802 MHPKKL PAR FEM EXT V40 TAPER 60MM C-M069-4-004 MHRH4X PAR C-TAPER EXTENSION PIECE 60 C-M069-5-102 MHRARE PAR V40 TAPER EXTENSION PIECE C-M069-5-103 MHRARH PAR V40 TAPER EXTENSION PIECE C-M069-5-104 MHRARJ PAR V40 TAPER EXTENSION PIECE C-M069-5-602 MHR3DH PAR V40 TAPER EXTENSION PIECE C-M069-5-603 MHR3E0 PAR V40 TAPER EXTENSION PIECE C-M069-5-604 MHR3DX PAR V40 TAPER EXTENSION PIECE C-M070-0-400 MHTPHK PAR V40 FEMORAL EXTENSION COMP C-M071-4-501 MJMVKP V40 FEMORAL EXTENSION COMPONEN C-M071-4-502 MJM0MW V40 FEMORAL EXTENSION COMPONEN C-M071-4-503 MJM1N5 V40 FEMORAL EXTENSION COMPONEN C-M071-8-001 MJP1N6 V40 FEMORAL EXTENSION COMPONEN C-M071-8-801 MJPVJ4 V40 FEMORAL EXTENSION COMPONEN C-M071-8-802 MJPEPK V40 FEMORAL EXTENSION COMPONEN C-M071-8-803 MJP9T9 V40 FEMORAL EXTENSION COMPONEN C-M072-0-901 MJR51TA C-TAPER FEMORAL EXTENSION COMP C-M072-0-902 MJR20A8 C-TAPER FEMORAL EXTENSION COMP C-M072-0-902 MJRVXNA C-TAPER FEMORAL EXTENSION COMP C-M072-0-903 MJRPR1A C-TAPER FEMORAL EXTENSION COMP C-M078-6-002 MLDP0A PAR EXTENSION PIECE C-TAPER 40 C-M079-0-602 MLE6V3 V40 FEMORAL EXTENSION COMPONEN KM15-3-502 RX1535B FEMORAL EXTENSION COMP 60mm KM15-3-503 RX1535C FEMORAL EXTENSION COMP 80mm KM15-3-504 RX1535D FEMORAL EXTENSION COMP 100mm KM16-9-203 RX1692D 45mm FEMORAL EXTENSION KM16-9-205 RX1692E 60mm FEMORAL EXTENSION KM19-1-302 RX1913C FEMORAL EXT 'C' TAPER - 50mm KM19-1-303 RX1913D FEMORAL EXT 'C' TAPER - 60mm KM19-1-304 RX1913E FEMORAL EXT 'C' TAPER - 80mm KM20-4-102 RX2041C PAR EXTENSION C-TAPER 40mm KM20-4-103 RX2041D PAR EXTENSION C-TAPER 50mm KM20-4-104 RX2041E PAR EXTENSION C-TAPER 60mm KM20-5-701 RX2057B PAR FEM EXTENSION - 60mm KM21-2-402 RX2124C FEM EXTENSION C-TAPER 40mm PAR KM21-2-403 RX2124D FEM EXTENSION C-TAPER 50mm PAR KM21-2-404 RX2124E FEM EXTENSION C-TAPER 60mm PAR KM21-5-302 RX2153C PAR FEMORAL EXTENSION - 40MM KM21-5-303 RX2153D PAR FEMORAL EXTENSION - 50MM KM21-5-304 RX2153E PAR FEMORAL EXTENSION - 60MM KM21-6-802 RX2168C FEM EXTENSION C-TAPER 40mm PAR KM21-6-803 RX2168D FEM EXTENSION C-TAPER 50mm PAR KM21-6-804 RX2168E FEM EXTENSION C-TAPER 60mm PAR KM21-7-702 RX2177C PAR FEM EXTENSION V40 - 40MM KM21-7-703 RX2177D PAR FEM EXTENSION V40 - 50MM KM21-7-704 RX2177E PAR FEM EXTENSION V40 - 60MM KM21-7-901 RX2179E PAR LOCKING SCREW KM21-7-902 RX2179C PAR FEMORAL EXTENSION - 40MM KM21-7-903 RX2179D PAR FEMORAL EXTENSION - 50MM KM21-9-402 RX2194C PAR FEM EXT C-TAPER 40MM KM21-9-403 RX2194D PAR FEM EXT C-TAPER 60MM KM21-9-404 RX2194E PAR FEM EXT C-TAPER 50MM KM21-9-405 RX2194F PAR FEM EXT 40MM KM21-9-406 RX2194G PAR FEM EXT 50MM KM21-9-407 RX2194H PAR FEM EXT 60MM KM22-8-702 RX2287C FEM EXTENSION C-TAPER 40mm PAR KM22-8-703 RX2287D FEM EXTENSION C-TAPER 50mm PAR KM22-8-704 RX2287E FEM EXTENSION C-TAPER 60mm PAR KM23-6-702 RX2367C PAR FEM EXT 40MM V40 KM23-6-703 RX2367D PAR FEM EXT 50MM V40 KM23-6-704 RX2367E PAR FEM EXT 60MM V40 KM23-7-403 RX2374D PAR FEM EXT 50MM V40 KM23-7-404 RX2374E PAR FEM EXT 60MM V40 KM23-7-503 RX2375D PAR FEM EXT 50MM V40 KM23-7-504 RX2375E PAR FEM EXT 60MM V40 KM23-7-902 RX2379C PAR FEM EXT 40MM V40 KM23-7-903 RX2379D PAR FEM EXT 50MM V40 KM23-7-904 RX2379E PAR FEM EXT 60MM V40 KM24-5-902 RX2459C PAR FEM EXTENSION V40 - 40MM KM24-5-903 RX2459D PAR FEM EXTENSION V40 - 50MM KM24-5-904 RX2459E PAR FEM EXTENSION V40 - 60MM KM26-0-902 RX2609C PAR FEM EXT 40MM FEM C-TAPER KM26-0-903 RX2906D PAR FEM EXT 50MM FEM C-TAPER KM26-0-904 RX2906E PAR FEM EXT 60MM FEM C-TAPER KM27-6-402 RX2764C PAR FEM EXT 40MM FEM C-TAPER KM27-6-403 RX2764D PAR FEM EXT 50MM FEM C-TAPER KM27-6-404 RX2764E PAR FEM EXT 60MM FEM C-TAPER KM28-3-700 RX3837A PAR FEM EXT - 80MM - V40 TAPER P-KM11-0-503 KM1105N6 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N9 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N7 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N11 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N31 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N51 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N11 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N41 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N81 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N101 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 X1105Q2 PAR FEMORAL EXTENSION 60MM P-KM11-0-504 KM1105D11 PAR FEMORAL EXTENSION 80MM P-KM11-0-504 KM1105D41 PAR FEMORAL EXTENSION 80MM P-KM11-0-504 KM1105D2 PAR FEMORAL EXTENSION 80MM P-KM11-0-504 KM1105D7 PAR FEMORAL EXTENSION 80MM P-KM11-0-505 KM1105E11 PAR FEMORAL EXTENSION 100MM P-KM11-0-505 KM1105E2 PAR FEMORAL EXTENSION 100MM
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Ms Colleen O'Meara
201-972-2100
Manufacturer Reason
for Recall
Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem.
FDA Determined
Cause 2
DESIGN: Device Design
Action Stryker Orthopaedics sent an Urgent Product Recall letter dated July 16, 2012 via Fed Ex with return receipt to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter requested customers to contact their Stryker Sales Representative to arrange for return of the affected product. Customers were instructed to fax back the attached Product Recall Acknowledgement Form to 201-821-6069. For questions call 201-972-2100.
Quantity in Commerce 301 units
Distribution Worldwide Distribution - US Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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