Z-1357-2015 Class II Terminated
FDA device recall Z-1357-2015 was initiated by DePuy Orthopaedics, Inc. on Feb 23, 2015 and is designated Class II. 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. The recall status is terminated (terminated Sep 28, 2015). Affected quantity: 54 of Lot No: SO2018074.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 8, 2015
- Initiation Date
- Feb 23, 2015
- Termination Date
- Sep 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54 of Lot No: SO2018074
Product Description
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) in CA; Ireland and Israel.
Code Information
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1357-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026