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U.S. Department of Health and Human Services

Class 2 Device Recall Ulnar Osteotomy Compression Plate, Short

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  Class 2 Device Recall Ulnar Osteotomy Compression Plate, Short see related information
Date Initiated by Firm April 16, 2018
Create Date August 18, 2018
Recall Status1 Terminated 3 on January 28, 2021
Recall Number Z-2877-2018
Recall Event ID 80487
510(K)Number K043263  
Product Classification Plate, fixation, bone - Product Code HRS
Product Ulnar Osteotomy Compression Plate, Short
Model: UOCP-S

Product Usage:
The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
Code Information Lot Numbers: 10003, 10017
Recalling Firm/
Manufacturer		 TriMed Inc.
27533 Avenue Hopkins
Santa Clarita CA 91355-3910
For Additional Information Contact
661-255-7406
Manufacturer Reason
for Recall		 Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate
FDA Determined
Cause 2		 Process control
Action Tri-Med issued notification on April 16, 2018 requesting: Determine the lot number of all Ulnar Osteotomy Compression Plates, Short (UOCP-S) .If you have UOCP-S plates with the lot numbers listed (10003, 10017): o Remove the UOCP-S plates from the tray and quarantine it. Do not use this plate. Contact TriMed at quality@trimedortho.com or call 800-633-7221. TriMed will arrange have the plate(s) returned to the company and replaced. Return the Recall Response card attached to this letter to TriMed as soon as possible. Contact TriMed via telephone or email as per below if you have any questions: Telephone*: 800-633-7221, Email: quality@trimedortho.com. TriMed will replace the potentially defective plates with plates that have been manufactured and confirmed to meet TriMeds specifications.
Quantity in Commerce 722
Distribution Worldwide Distribution in the state of TX and countries of Australia, China Sweden
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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