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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCAR Recall
| Reference Number: |
mdprc 043 10 12 000 |
| Date submitted: |
10/15/2012 |
| Manufacturer: | Synthes Inc |
| Device Type: | Craniofacial bone distractor, Mandible Distractor Multiaxial |
| Description: | Craniofacial bone distractor |
| Medical Device Identifier: | Part Number (Part Description; Lot Number):
487.931 (Distractor Body, Titanium Alloy (TAV); 7895264, 7793390, 7583381, 7583380, 7528840, 3708643, 3683421, 3683403, 3560888);
487.966 (Mandible Distractor, multiaxial, right, Titanium Alloy (TAV); 7765627, 7562081, 7532790, 3800757, 3757207);
487.967 (Mandible Distractor, multiaxial, left, Titanium Alloy (TAV); 7834374, 7662788, 7562083, 3757213, 3739743)
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| Reason of Field Safety Corrective Action: | A reported complaint of missing outer sheer pin. The inner diameter (for fixing the sheer pin) of the worm gear component was out of specification. |
| Remedy Action: | For patients who may be undergoing treatment with this device, it is advised to contact the patient to check if the device they have is one of the effected lots see attached. Synthes decided to remove all potential affected parts from the field.
Synthes is requesting that you immediately cease using the product and please examine your inventory for the above effected lot numbers and remove them. When in doubt, please
remove the product and provide it to your Synthes Sales Representative.
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| Athorized Representative/Importer/Distributor: | Isam Economic Co., Riyadh, (01) 4600846 |
| Report Source: | NCAR |
| Source Ref. Number: | CH-2012-10-04-055 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Synthes Inc.pdf |
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