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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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 Class 2 Device Recall Stryker Orthopaedics see related information
Date Posted November 13, 2012
Recall Status1 Terminated on September 09, 2015
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-
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
201-831-5523
For Additional Information Contact Ms Christie Samsa
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
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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