—#166941

Product

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

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K110145
Affected lot / code info: Lot Numbers: 053940, 545740, 067490, 664610, 165770, 676180, 165830, 688250, 415590, 860050

Why it was recalled

Expiration date incorrectly listed on the label

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: AZ CO FL FL GA LA MA MA MO NY SC TX

Timeline

Recall initiated: 2018-08-03
Terminated: 2020-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166941. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.