FDAClass IIAugust 12, 2020

Suturefix Ultra Suture recall

SUTUREFIX ULTRA Suture, Product number 72203855

Why was Suturefix Ultra Suture recalled?

A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.

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?

Lot numbers 2038366, 2039311 and 2046505

Product
SUTUREFIX ULTRA Suture, Product number 72203855
Recalling firm
Smith & Nephew, Inc.
Quantity
868
Distribution
Domestic distribution to AL AR AZ CO GA IL IN KS KY MD MN MO NC NE NJ NY OK PA PR TN TX VA WI. Foreign distribution to Australia Austria Belgium Finland France Germany Great Britain Ireland Italy Japan Luxembourg Mexico Netherlands Poland Portugal Singapore South Africa Spain Sweden Switzerland
Recall date
August 12, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls