Recall Z-0918-2018 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04
| Date | Oct 3, 2017 |
| Status | Terminated |
| Reason | 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 | Labeling design |
| 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. |
| Quantity | 457 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.