Recall Z-2362-2020 ยท LXH Orthopedic Manual Surgical Instrument
Biomet
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
| Date | May 1, 2020 |
| Status | Terminated |
| Reason | Device and tray that houses the device did not pass steam sterilization process validation testing |
| Root cause | Process design |
| Action | Zimmer Biomet issued letter dated 5/1/20 to Distributors,Risk Managers and Surgeons, states reason for recall, health risk and action to take: Risk Manager Responsibilities: 1. Review this 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. If the product has been further distributed, provide your customers with the recall notice for hospitals a |
| Quantity | 136 units |
| Distribution | Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.