| Date Initiated by Firm | November 20, 2023 |
|---|
| Date Posted | January 03, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0630-2024 |
|---|
| Recall Event ID |
93522 |
| 510(K)Number | K203000 |
|---|
| Product Classification |
Mouthguard, prescription - Product Code MQC
|
| Product | KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental
appliances such as mouthguards, nightguards, splints, repositioners, and retainers
Item No.: 4220011 |
|---|
| Code Information |
UDI: UDI +H66842200111/$$3251116NB3628L
Lot No. NB3628 |
| FEI Number |
3010002722
|
Recalling Firm/
Manufacturer |
Keystone Industries
480 S Democrat Rd
Gibbstown NJ 08027-1239
|
| For Additional Information Contact | SAME
856-663-4700 |
|---|
Manufacturer Reason
for Recall | Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU). |
|---|
FDA Determined
Cause 2 | Labeling mix-ups |
|---|
| Action | Keystone Industries issued Urgent Medical Device Recall/Correction letter to Distributors
between 10/20/2023 and 10/23/2023. Letter states reason for recall, health risk and action to take:
For immediate access, the correct IFU is available following this link: 4916111-NATLAB-1372-KeySplint_Hard_DOMESTIC_IFU_WEB.pdf (keystoneindustries.com)
IMMEDIATE ACTIONS TO BE TAKEN
1. Review product inventory and quarantine all affected product on hand. Open
zip lock bag and remove the incorrect IFU. Place an X across the front panel
of the IFU using a marker or pen. Take a picture of the IFU with an X then
discard the IFUs. Record the information on the attached acknowledgement
form.
2. Keystone Industries will send you the correct IFUs for any items remaining in
your inventory upon receipt of the acknowledgement form.
3. Review distribution records and identify all customers who were shipped the
affected product lot.
4. Send End User Notifications provided to you with this notification to all
identified customers that received product. Record evidence of notification on
the acknowledgement form.
Complete the attached Acknowledgement of Medical Device Recall Form and
return within 5 days of receiving this notice. Email the completed form to
amcclure@keystoneind.com
If you have any questions after reviewing this notice, please email using the
address below or call Caleb Barylski at 856-548-5205 between 8:00 am and 5:00
pm EST, Monday through Friday. |
|---|
| Quantity in Commerce | 336 units |
|---|
| Distribution | Worldwide distribution - US Nationwide and the country of China. |
|---|
| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = MQC
|
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