Recall Z-0516-2018 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
| Date | Jun 12, 2017 |
| Status | Terminated |
| Reason | A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture |
| Root cause | Nonconforming Material/Component |
| Action | On June 12, 2017, Zimmer Biomet distributed Urgent Medical Device Recall Removal and Certificates of Acknowledgement notices to their customers via email and FedEx. Risk Manager Customer Responsibilities are the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative and quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete and return the Certificate of Acknowledgement via email to: corporatequality.postmarket@zimmerbiom |
| Quantity | 1,524 units |
| Distribution | AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV. Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.