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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 033 04 18 000 |
| Date submitted: |
4/8/2018 |
| Manufacturer: | DePuySynthes |
| Device Type: | Retractor f/Sciatic Nerve & Retractor f/Sciatic Nerve long |
| Description: | Retractors, Surgical, Nerve |
| Medical Device Identifier: | -Part Number:03.100.013, Description: Retractor f/Sciatic Nerve Affected Lot Numbers: T104992, T114599, T140390, T140674, T140675, T140676, T140677, T141539, T143644, T144855, T145296, T145589, T145819, T146660, T147930, T148624, T149725, T149726, T151370, T152806, T152807, T153692, T155648, T156708, T160394, T939640, T987813
-Part Number: 03.100.014 Part Description: Retractor f/Sciatic Nerve long Lot Numbers: T104993, T108115, T114598, T140566, T140665, T140670, T140671, T140673, T141540, T143687, T144854, T145585, T145590, T145932, T146657, T147929, T148552, T148553, T149727, T149728 T151369, T151488, T152808, T152809, T153884, T155649, T958061
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| Reason of Field Safety Corrective Action: | There is the potential for micropores to form on the hollow handle of the Sciatic Nerve Retractor. |
| Remedy Action: | 1. Immediately review your inventory to identify and quarantine the affected products listed above in a manner that ensures the affected products will not be used.
2. Review, complete, sign and return the attached reply form on page 3 of this letter to your local DePuy Synthes sales organization in accordance with the directions on the form within 5 business days of receipt of this notification.
3. Return the affected products within 30 business days. A credit note will be issued for the returned items. Please note, there are no replacement products available at this time.
4. Forward this notice to anyone in your facility that needs to be informed.
5. If the affected products have been forwarded to another facility, contact that facility to arrange return.
6. Maintain awareness of this notice until the products have been returned.
7. Keep a copy of this notice.
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| Athorized Representative/Importer/Distributor: | Johnson & Johnson Medical Meddile East |
| Report Source: | NCMDR |
| Source Ref. Number: | 45F5DC90C636C |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Synthes GmbH.pdf |
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