Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;
FDA Recall Z-0772-2021 · Posted None
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Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeJDS
Date Initiated2020-11-02
Date Terminated2023-01-06
Product Quantity41 units
Reason for Recall
Manufacturing packaging error.
Firm Action
On 11/02/2020 the firm send a letter 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 [email protected].
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 [email protected].
Root Cause
Packaging process control
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, KY, MI, NC, NJ, OH, PA, TN, TX, WA and the countries of AU, CA & GB.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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