Recall Z-2875-2018 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
Connecting Bolt, Model 14-442093
| Date | Jun 18, 2018 |
| Status | Terminated |
| Reason | Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture. |
| Root cause | Employee error |
| Action | Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service. Risk Manager were advised to take the following actions: 1. Review the notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete and return the Certificate of Acknowledgement form via email to CorporateQuality.PostMarket@zimmerbiomet.com. This form m |
| Quantity | 247 units |
| Distribution | AR, AZ, CA, FL, GA, IN, KY, LA, MA, MI, MN, MO, MT, NJ, NY, OH, SC, TX, UT & WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.