Date Initiated by Firm | September 28, 2018 |
Create Date | November 12, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0355-2020 |
Recall Event ID |
83820 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product | TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA. |
Code Information |
Lot number 91401455 |
Recalling Firm/ Manufacturer |
TriMed Inc. 27533 Avenue Hopkins Santa Clarita CA 91355-3910
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For Additional Information Contact | Mr. David Medoff 661-255-7406 |
Manufacturer Reason for Recall | The epoxy on Apex manufactured epoxy-coated instruments can pop off. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | The recalling firm issued letters via email on 9/28/2018 explaining the reason for recall and requesting consignees to identify potentially-affected product and quarantine it until a TriMed representative is able to conduct an inspection. |
Quantity in Commerce | 99 instruments |
Distribution | Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden. |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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