FDAClass IINovember 24, 2021

Smith and Nephew EVOS Self-Tapping Locking Screw SST recall

Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.

Why was Smith and Nephew EVOS Self-Tapping Locking Screw SST recalled?

The labels on the packages of screws were switched.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

REF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743.

Product
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Recalling firm
Smith & Nephew, Inc.
Quantity
224 units
Distribution
Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand.
Recall date
November 24, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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