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Terminated

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 Recall Z-3252-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeMBI
Date Initiated2018-08-03
Date Terminated2020-04-10
Product Quantity217 units

Reason for Recall

Expiration date incorrectly listed on the label

Firm 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 :[email protected]

Root Cause

Device Design

Distribution Pattern

AZ CO FL FL GA LA MA MA MO NY SC TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110145BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHORBiomet, Inc. · 2011-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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