—#161654

Product

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All lots

Why it was recalled

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.

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

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.

Timeline

Recall initiated: 2017-10-03
Terminated: 2018-08-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161654. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.