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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 Initiated by Firm July 16, 2012
Date Posting Updated November 13, 2012
Recall Status1 Terminated 3 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 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 NJ 07430
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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