Z-1357-2015Class II

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

Name: Z-1357-2015 RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation
Creator: DePuy Orthopaedics, Inc.
Published: 2015-02-23
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2015-02-23 / Terminated

FDA source

DePuy Orthopaedics, Inc. began a recall of RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation on 2015-02-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1357-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-23
Posted: 2015-03-31
Terminated: 2015-09-28
Recalling firm: Depuy Orthopaedics Inc.
Product: RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
FDA root cause: Under Investigation by firm
Action: 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: [email protected]
Quantity in commerce: 54 of Lot No: SO2018074
Distribution: Worldwide Distribution: US (nationwide) in CA; Ireland and Israel.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1357-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1357-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-31

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)