Z-0366-2020 Class II Terminated
FDA device recall Z-0366-2020 was initiated by TriMed Inc. on August 15, 2018 and is designated Class II. Reason for recall: 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. The recall status is terminated. Affected quantity: 583 Bone Plates.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- August 15, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 583 Bone Plates
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of MD, UT.
Code Information
Lot # 110631,