Recall Z-0734-2019 ยท FSM Tray, Surgical, Instrument
Zimmer Biomet, Inc.
Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
| Date | Nov 28, 2018 |
| Status | Terminated |
| Reason | There is a potential for silicone shedding during cleaning and sterilization. |
| Root cause | Process control |
| Action | Urgent Medical Device Correction notification letters dated 11/28/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken. |
| Quantity | 971 i nTotal |
| Distribution | Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.