Z-0366-2020Class II

TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 -

Name: Z-0366-2020 TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 -
Creator: TriMed Inc.
Published: 2018-08-15
License: https://open.fda.gov/license/

Trimed Inc / initiated 2018-08-15 / Terminated / root cause: manufacturing process

FDA source

TriMed Inc. began a recall of 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... on 2018-08-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0366-2020
Classification: Class II
Status: Terminated
Initiated: 2018-08-15
Posted: 2019-11-13
Recalling firm: Trimed Inc
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.
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 implanted, medical judgment should be applied to determine whether additional patient monitoring activities should be performed to evaluate implant placement, implant structural integrity, and fracture union. 3. Return the Recall Response card attached to this letter to TriMed as soon as possible. 4. Please contact TriMed via telephone or email as per below if you have any questions:, Telephone*: 800-633-7221 Email: [email protected], Hours of operation: 8:00AM to 5:00PM PST (Monday through Friday, excluding holidays)
Quantity in commerce: 583 Bone Plates
Distribution: US Nationwide distribution in the states of MD, UT.
Product codes and lots: Lot # 110631.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0366-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0366-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-13

Product code HRS

K060041Class IITrimed Bone PlatesTriMed, Inc. / cleared 2006-02-07

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)