Smith & Nephew, Inc. SUTUREFIX ULTRA Suture, Product number 72203855 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On June 24, 2020, the firm distributed Urgent Medical Device Recall Notices to their customers. Customers were informed that due to a packaging error, packages labeled as a 1.7mm twist drill (S) instead contained a 1.7mm (XL) drill. The overall length of the XL drill (12 inches) is longer than the S drill (11 inches). Customers were asked to do the following: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with the Urgent Medical Device Recall Notice, and quarantine them immediately. 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. 2. If you have no product to return, please indicate this on the response form included with the letter. 3. If you have product to return, please list the item, batches and quantities that you are returning on the customer response form. 4. Complete the remainder of the customer response form, sign and send to FieldActions@smith-nephew.com. 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.

Distribution

As reported by FDA

AL, AZ, AR, CO, GA, IL, IN, KS, KY, MD, MN, MO, NE, NJ, NY, NC, OK, PA, TN, TX, VA, WI, PR