| Class 2 Device Recall Sirus Drill 13mm diameter trauma instrument; Model Number: 02.00020.040 |  |
Date Initiated by Firm | October 03, 2017 |
Create Date | March 06, 2018 |
Recall Status1 |
Terminated 3 on August 20, 2018 |
Recall Number | Z-0919-2018 |
Recall Event ID |
79206 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product | Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040 |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
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For Additional Information Contact | 411 Technical Services 574-371-3071 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 127 |
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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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