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.
FDA Recall Z-2685-2020 · Posted None
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Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeJDS
Date Initiated2020-06-24
Date Terminated2021-04-28
Product Quantity12 units
Reason for Recall
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Firm 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 [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
Reprocessing Controls
Distribution Pattern
International distribution in the countries of Brazil, Colombia and United Arab Emirates.
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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