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U.S. Department of Health and Human Services

Class 2 Device Recall RECLAIM Revision Hip System; Assembled Implant Inserter Adaptor

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  Class 2 Device Recall RECLAIM Revision Hip System; Assembled Implant Inserter Adaptor see related information
Date Initiated by Firm February 23, 2015
Date Posted March 31, 2015
Recall Status1 Terminated 3 on September 28, 2015
Recall Number Z-1357-2015
Recall Event ID 70692
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Code Information CATALOG NO. : 2975-00-920:  Barcode (GTIN): 10603295156192 Lot No. Distribution SO2018074 (Distributed) SO2018072 (Not Distributed) SO2018073 (Not Distributed) SO2018075 (Not Distributed) SO2018080 (Not Distributed)
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Tia L. Holmes-Johnson
574-371-4577
Manufacturer Reason
for Recall		 This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm issued a voluntary device removal on 02/23/2015 for lot no. SO2018074 of the RECLAIM¿ Assembled Implant Inserter Adaptor. The recall notice informs US Distributors and Medical Professionals about the issue and any actions to take. US Distributors will return affected instruments and notify one Hospital/User Facility with the Hospital Notice and Reconciliation Forms. Reconciliation forms are required for the end-user Hospital/Medical Facility Consignee. Customers may contact Mindy K. Tinsley Director Wordwide Communications Tel: (574) 372-7136 Fax: (574) 372-7717 E-mail: mtinsley@its.jnj.com
Quantity in Commerce 54 of Lot No: SO2018074
Distribution Worldwide Distribution: US (nationwide) in CA; Ireland and Israel.
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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