Device product
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.
Z-0366-2020
Product summary
- Firm
- TriMed Inc.
- Event
- Event 83984
- Status
- Terminated
- Classification
- Class II
- Quantity
- 583 Bone Plates
- Official record key
device-enforcement:Z-0366-2020
Official wording
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.
Code information: Lot # 110631,
Distribution pattern: US Nationwide distribution in the states of MD, UT.
Derived failure modes
-
Unknown
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.