Recall Z-3252-2018
Zimmer Biomet, Inc. · initiated August 3, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Numbers: 053940, 545740, 067490, 664610, 165770, 676180, 165830, 688250, 415590, 860050
Reason for recall
Expiration date incorrectly listed on the label
FDA-determined cause: Device Design
Action taken
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
Details
- Recall number
- Z-3252-2018
- Initiated
- August 3, 2018
- Terminated
- April 10, 2020
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Quantity
- 217 units
- Distribution
- AZ CO FL FL GA LA MA MA MO NY SC TX
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN