| Date Initiated by Firm | July 15, 2020 |
|---|
| Create Date | September 10, 2020 |
|---|
| Recall Status1 |
Terminated 3 on January 03, 2024 |
| Recall Number | Z-2951-2020 |
|---|
| Recall Event ID |
86165 |
| 510(K)Number | K192348 |
|---|
| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product | SICAT IMPLANT V2.0 |
|---|
| Code Information |
V2.0 |
| FEI Number |
3006098230
|
Recalling Firm/
Manufacturer |
SICAT GMBH & CO. KG
Brunnenallee 6
Bonn Germany
|
Manufacturer Reason
for Recall | A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD. |
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FDA Determined
Cause 2 | Software design |
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| Action | On 07/15/2020 customer notification letter was sent to all users/customers who have the 2.0 version of the software installed in the system. These users are instructed to only use the system for specific cases as defined in the field safety notice. The firm plans on implementing a new software version in July 2020 to correct the issues found. |
|---|
| Quantity in Commerce | 853 units |
|---|
| Distribution | Worldwide distribution |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = LLZ
|
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