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U.S. Department of Health and Human Services

Class 2 Device Recall TriMed Bone Plates

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  Class 2 Device Recall TriMed Bone Plates see related information
Date Initiated by Firm August 15, 2018
Create Date November 13, 2019
Recall Status1 Terminated 3
Recall Number Z-0366-2020
Recall Event ID 83984
510(K)Number K060041  
Product Classification Plate, fixation, bone - Product Code HRS
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.
Code Information Lot # 110631.
Recalling Firm/
Manufacturer		 TriMed Inc.
27533 Avenue Hopkins
Santa Clarita CA 91355-3910
For Additional Information Contact
661-255-7406
Manufacturer 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.
FDA Determined
Cause 2		 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 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: quality@trimedortho.com, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = TRIMED, INC.
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