FDAClass IIApril 8, 2015

RECLAIM Assembled Implant Inserter Adaptor orthopedic recall

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

Why was RECLAIM Assembled Implant Inserter Adaptor orthopedic 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

Product
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
54 of Lot No: SO2018074
Distribution
Worldwide Distribution: US (nationwide) in CA; Ireland and Israel.
Recall date
April 8, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls