FDA-Device2015-04-08Class II

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

DePuy Orthopaedics, Inc.
Hazard

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.

Sold states
Worldwide Distribution: US (nationwide) in CA; Ireland and Israel.
Affected count
54 of Lot No: SO2018074
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1357-2015

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