DePuy Orthopaedics product recalled over possible plastic fragments

Recall date

February 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

DePuy Orthopaedics, Inc. recalls RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.

Recall number

Z-1357-2015

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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