FDA-Device2019-11-20Class II
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.
TriMed Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of MD, UT.
Affected count
583 Bone Plates
Manufactured in
27533 Avenue Hopkins, N/A, Santa Clarita, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0366-2020Don't want to check this manually?
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