Recall Z-1542-2020 ยท HTO Reamer
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
FlipCutter III Drill
| Date | Jan 20, 2020 |
| Status | Terminated |
| Reason | There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier. |
| Root cause | Packaging process control |
| Action | Consignees are instructed to return the affected devices which will be replaced. |
| Quantity | 6625 units |
| Distribution | Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.