Recall Z-3252-2018 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Zimmer Biomet, Inc.
Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992
| Date | Aug 3, 2018 |
| Status | Terminated |
| Reason | Expiration date incorrectly listed on the label |
| Root cause | Device Design |
| Action | Zimmer notified distributors on 8/3/18 distributors notified via email. Hospital risk managers, as well as distributors with product, notified via Fed'X. The letter identifies the issue and their responsibilities, locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory. Product to be returned to Zimmer Biomet. Question customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday or to :CorporateQuality.PostMarket@zimmerbiomet.com |
| Quantity | 217 units |
| Distribution | AZ CO FL FL GA LA MA MA MO NY SC TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110145 | BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR Biomet, Inc., Mar 4, 2011 |