Recall Z-1357-2015 ยท LXH Orthopedic Manual Surgical Instrument
DePuy Orthopaedics, Inc.
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
| Date | Mar 31, 2015 (initiated Feb 23, 2015) |
| Status | Terminated |
| 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.jn |
| Quantity | 54 of Lot No: SO2018074 |
| Distribution | Worldwide Distribution: US (nationwide) in CA; Ireland and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.