—#182151

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.

FDA product code: JDS — Nail, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K061019
Affected lot / code info: Model: 71655139 Lot: 19BM13592A

Why it was recalled

A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.

Root cause (FDA determination)

Reprocessing Controls

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: International distribution in the countries of Brazil, Colombia and United Arab Emirates.

Timeline

Recall initiated: 2020-06-24
Terminated: 2021-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182151. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.