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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 108 01 12 000 |
| Date submitted: |
1/30/2012 |
| Manufacturer: | Stryker Orthopaedics |
| Device Type: | Implants, Knee. Scorpio Tibial Punch Tower |
| Description: | Implants, Knee |
| Medical Device Identifier: | Catalog #: 8000-1 089.
Lot #: RD5N406, RD5N407, RD5S103, RD5S104, RD5S259, RD5S300, RD5T177, RD5T178, RD5T179, RD5T298, RD5V238, RD5V239, RD5V240, RD5V260, RD5W267, RD5W268, RD5W320, RD5W381, RD6A096, RD6C178, RD6E082, RD6E083, RD6E086, RD6E087, RD6E089, RD6E090, RD6E091, RD6E158, RD6E159, RD6E160, RD6E186, RD6E187
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| Reason of Field Safety Corrective Action: | The slot that guides the stem of the keel punch into the channel of the tibial punch tower may be undersized. |
| Remedy Action: | Immediately check your internal inventory. Locate and quarantine all subject devices pending return to your local Stryker Distributor. |
| Athorized Representative/Importer/Distributor: | Al-Faisaliah Medical System, Riyadh, (01) 2119999 |
| Report Source: | NCMDR |
| Source Ref. Number: | 0895954D05184 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Stryker Orthopaedics.pdf |
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