Device product
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Z-1357-2015
Product summary
- Event
- Event 70692
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54 of Lot No: SO2018074
- Official record key
device-enforcement:Z-1357-2015
Official wording
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.
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)
Distribution pattern: Worldwide Distribution: US (nationwide) in CA; Ireland and Israel.
Derived failure modes
-
Foreign material or chemical contamination
plastic pieces