—#134495

Product

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 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)

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

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

Timeline

Recall initiated: 2015-02-23
Posted by FDA: 2015-03-31
Terminated: 2015-09-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134495. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.