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

FDA device recall Z-1357-2015 · posted 2015-03-31 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Terminated

Product code

LXH

Quantity affected

54 of Lot No: SO2018074

Distribution

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

Date initiated

2015-02-23

Date posted

2015-03-31

Date terminated

2015-09-28

Location

Warsaw, IN