Recall Z-2746-2020 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Smith & Nephew, Inc.
SUTUREFIX ULTRA Suture, Product number 72203855
| Date | Jun 24, 2020 |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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 no |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122059 | ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS Smith & Nephew, Inc., Mar 18, 2013 |