Recall Z-0366-2020 ยท HRS Plate, Fixation, Bone
TriMed Inc.
TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.
| Date | Aug 15, 2018 |
| Status | Terminated |
| Reason | The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified. |
| Root cause | Employee error |
| Action | On 08/15/2019 and 9/13/19, the firm issued a recall notice to affected consignees via email. The recall notification informed consignees of the following: 1. Review your inventory to see if you have any of the impacted product. If you have impacted product within your inventory, remove the product use. Do not implant the impacted product. Contact TriMed at quality@trimedortho.com or call 800-633-7221. TriMed will arrange to have the impacted product returned to the company. 2. Review your records to see if the impacted product was implanted. If you have records that impacted product was i |
| Quantity | 583 Bone Plates |
| Distribution | US Nationwide distribution in the states of MD, UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060041 | TRIMED BONE PLATES TriMed, Inc., Feb 7, 2006 |