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Terminated

RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.

FDA Recall Z-1357-2015 · Posted 2015-03-31

Recalling FirmDePuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2015-02-23
Date Terminated2015-09-28
Product Quantity54 of Lot No: SO2018074

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.

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: [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution: US (nationwide) in CA; Ireland and Israel.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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