| Date Initiated by Firm | June 24, 2020 |
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| Create Date | July 22, 2020 |
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| Recall Status1 |
Terminated 3 on April 28, 2021 |
| Recall Number | Z-2685-2020 |
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| Recall Event ID |
85920 |
| 510(K)Number | K061019 |
|---|
| Product Classification |
Nail, fixation, bone - Product Code JDS
|
| Product | TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place. |
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| Code Information |
Model: 71655139 Lot: 19BM13592A |
| FEI Number |
1020279
|
Recalling Firm/
Manufacturer |
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
|
| For Additional Information Contact |
901-396-2121 |
|---|
Manufacturer Reason
for Recall | A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve. |
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FDA Determined
Cause 2 | Reprocessing Controls |
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| Action | On 06/24/2020 the firm sent an email to its consignees with the following instructions:
Required Actions:
1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately.
a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the
required actions are complete.
b. Include the customers account number and name in the table below.
2. If you have no product to return, please put an X in the appropriate location below.
3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below.
4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com.
Please Note even if you have no product to return, this form must be completed, signed and returned.
5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number.
If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com. |
|---|
| Quantity in Commerce | 12 units |
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| Distribution | International distribution in the countries of Brazil, Colombia and United Arab Emirates. |
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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 = JDS
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