FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
- Recall number
- Z-1357-2015
- Recalling firm
- DePuy Orthopaedics, Inc.
- Product
- RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
- Status
- Terminated
- Initiated
- 2015-02-23
- Posted
- 2015-03-31
- Terminated
- 2015-09-28
- Reason
- 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
- 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: mtinsley@its.jnj.com
- Quantity
- 54 of Lot No: SO2018074
- Distribution
- Worldwide Distribution: US (nationwide) in CA; Ireland and Israel.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28