| Date Initiated by Firm | December 19, 2016 |
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| Date Posted | January 06, 2017 |
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| Recall Status1 |
Terminated 3 on February 01, 2017 |
| Recall Number | Z-0953-2017 |
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| Recall Event ID |
76104 |
| 510(K)Number | K160995 |
|---|
| Product Classification |
Plate, fixation, bone - Product Code HRS
|
| Product | NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France
The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius |
|---|
| Code Information |
Lot Numbers: 1604154, 1605083, 1606068 |
Recalling Firm/
Manufacturer |
In2Bones, SAS
28 Chemin du petit Bois
Ecully France
|
| For Additional Information Contact | Joe Clift
844-602-6637 |
|---|
Manufacturer Reason
for Recall | Dimensional non-conformity of the thread on the screw head. |
|---|
FDA Determined
Cause 2 | Component design/selection |
|---|
| Action | IN2BONES en a Field Safety Corrective Action letter dated December 15, 2016, to the sole US distributor. The letter identified the product, the problem, and the action to be taken by the customer. We therefore recommend you to follow the instructions here below:
1. Identify all the devices with the batches subject of this recall that might still be in your inventory
and quarantine them
2. Inform and distribute this Recall Notification to all relevant persons within your organization
3. To distributors only: Identify all the devices with the batches subject of this recall that were
delivered to your customers, and if relevant, instruct them to also follow these instructions
(identification and quarantine)
4. Fill in and return the fax back form enclosed. With this form, you will certify that you have
received this Recall Notification and intend to comply with the recommendations listed. This fax
back form will enable In2Bones to conduct effectiveness checks.
Customers with questions were instructed to contact the Quality and Regulatory Affairs team at +33 4 72 29 26 26 / +33 7 61 88 44 30 or by email:
qualte@in2bones.com.
For questions regarding this recall call 844-602-6637. |
|---|
| Quantity in Commerce | 40 units |
|---|
| Distribution | Worldwide Distribution - US TN only and Internationally to France and Switzerland |
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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 = HRS
|
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