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U.S. Department of Health and Human Services

Class 2 Device Recall POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar)

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  Class 2 Device Recall POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar) see related information
Date Initiated by Firm July 24, 2017
Create Date August 29, 2017
Recall Status1 Terminated 3 on August 21, 2020
Recall Number Z-3100-2017
Recall Event ID 77827
510(K)Number K130728  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only
The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument
Code Information Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
978-749-1440
Manufacturer Reason
for Recall		 The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
FDA Determined
Cause 2		 Device Design
Action Smith & Nephew sent an Urgent Medical Device Recall Notice dated July 24, 2017, to all affected consignees. The firm notified their consignees by email and Fed Ex on 07/24/2017. Consignees have been asked to inspect inventory to locate and quarantine affected product. All consignees were asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew. Customers with questions were instructed to contact FieldActions@smith-nephew.com. For questions regarding this recall call 978-749-1440.
Quantity in Commerce 402 units
Distribution Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
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.
510(K) Database 510(K)s with Product Code = LZO and Original Applicant = SMITH & NEPHEW, INC.
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