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Terminated

Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04

FDA Recall Z-0918-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-10-03
Date Terminated2018-08-20
Product Quantity457

Reason for Recall

The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications.

Firm Action

Review the notification and ensure affected personnel are aware of contents. Assist Zimmer Biomet sales representative in locating and quarantining affected product. Sales representative will remove product from facility. Complete certificate of acknowledgement and return to Zimmer Biomet. Distributors are asked to locate and quarantine all affected product in inventory and from affected hospitals in their territory.

Root Cause

Labeling design

Distribution Pattern

Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.

Official Source

View FDA Recall →

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

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