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U.S. Department of Health and Human Services

Class 2 Device Recall Hex Driver

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 Class 2 Device Recall Hex Driversee related information
Date Initiated by FirmJanuary 11, 2018
Create DateApril 12, 2018
Recall Status1 Terminated 3 on January 18, 2024
Recall NumberZ-1373-2018
Recall Event ID 79224
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductHex 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
ActionRecall 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 Commerce1525 devices
DistributionUS, China, Latin America
Total Product Life CycleTPLC 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.
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