| Date Initiated by Firm | October 30, 2020 |
|---|
| Create Date | January 26, 2021 |
|---|
| Recall Status1 |
Terminated 3 on August 11, 2021 |
| Recall Number | Z-0929-2021 |
|---|
| Recall Event ID |
87060 |
| 510(K)Number | K173402 |
|---|
| Product Classification |
Dental stereotaxic instrument - Product Code PLV
|
| Product | DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS) |
|---|
| Code Information |
Work Order (Lot) Number 1573 |
| FEI Number |
3012787974
|
Recalling Firm/
Manufacturer |
Neocis, Inc.
530 NW 29th St
Miami FL 33127-3917
|
| For Additional Information Contact | Dr. Alon Mozes, PhD
786-483-7490 |
|---|
Manufacturer Reason
for Recall | The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | The firm initiated the recall by letter on 10/30/2020 via UPS overnight delivery. The letter explains the issue, refers to the original recall and requests that the consignee set aside any affected product. Neocis Field Personnel will inspect the devices and return them to the manufacturing facility. |
|---|
| Quantity in Commerce | 100 units |
|---|
| Distribution | OH, FL, CT, MA, AZ PA, NY |
|---|
| 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 = PLV
|
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