Recall Z-2746-2020— Smith & Nephew, Inc.

Name: FDA recall Z-2746-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-24

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-06-24. It names one FDA 510(k) clearance: K122059. Product: SUTUREFIX ULTRA Suture, Product number 72203855. Reason: 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..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-06-24
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K122059 — ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORSSmith & Nephew, Inc.·cleared 2013-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SUTUREFIX ULTRA Suture, Product number 72203855

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.