Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Hex Driver

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Hex Driver see related information
Date Initiated by Firm January 11, 2018
Create Date April 12, 2018
Recall Status1 Terminated 3 on January 18, 2024
Recall Number Z-1373-2018
Recall Event ID 79224
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
Code Information Affected lot numbers: 922361, 922362, 91956, 91957, 92237, 92238, 91858, 92235, 92656, 91856, 91857
Recalling Firm/
Manufacturer		 TriMed Inc.
27533 Avenue Hopkins
Santa Clarita CA 91355-3910
For Additional Information Contact
661-255-7406
Manufacturer Reason
for Recall		 Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.
FDA Determined
Cause 2		 Process control
Action Recall notification letters were sent to affected consignees on January 16, 2018. The consignee letter requests that the consignee return an initial Acknowledgement & Receipt Form to TriMed by January 23, 2018.
Quantity in Commerce 1525 devices
Distribution US, China, Latin America
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.
-
-