—#182372

Product

SUTUREFIX ULTRA Suture, Product number 72203855

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K122059
Affected lot / code info: Lot numbers 2038366, 2039311 and 2046505

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 150 Minuteman Rd, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2020-06-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182372. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.