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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCAR Recall
| Reference Number: |
mdprc 047 09 11 000 |
| Date submitted: |
9/17/2011 |
| Manufacturer: | Zimmer |
| Device Type: | Hip prosthesis, Biolox OPTION Ceramic Femoral Head |
| Description: | Hip prosthesis, internal, femoral component. |
| Medical Device Identifier: | All reference numbers:
00-8777-028-01, 00-8777-028-02, 00-8777-028-03, 00-8777-028-04, 00-8777-032-01, 00-8777-032-02, 00-8777-032-03, 00-8777-032-04, 00-8777-036-01, 00-8777-036-02, 00-8777-036-03, 00-8777-036-04, 00-8777-040-01, 00-8777-040-02, 00-8777-040-03, 00-8777-040-04, 00-8778-028-01, 00-8778-028-02, 00-8778-028-03, 00-8778-032-01, 00-8778-032-02, 00-8778-032-03, 00-8778-036-01, 00-8778-036-02,00-8778-036-03, 00-8778-040-01, 00-8778-040-02, 00-8778-040-03
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| Reason of Field Safety Corrective Action: | The manufacturer has determined that the current information as described in the Instructions for Use (IFU) and in the product brochure was confusing. |
| Remedy Action: | The manufacturer has updated the text of the IFU and product information brochure.
The revised IFU and a copy of the Field Safety Notice will be delivered with the implants in order to inform the surgeon.
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| Athorized Representative/Importer/Distributor: | Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733 |
| Report Source: | NCAR |
| Source Ref. Number: | CH-2011-09-13-033 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: | No Attachments |
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