Recall Z-1961-2019 ยท FSM Tray, Surgical, Instrument
Zimmer Biomet, Inc.
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
| Date | Jun 10, 2019 |
| Status | Terminated |
| Reason | Lack of an adequate sterilization validation. |
| Root cause | Under Investigation by firm |
| Action | Medical Device Recall notification letters dated 6/10/19 were sent to customers. |
| Quantity | 1257 |
| Distribution | The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.