| Date Initiated by Firm | May 16, 2018 |
|---|
| Create Date | August 28, 2018 |
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| Recall Status1 |
Terminated 3 on August 24, 2020 |
| Recall Number | Z-2945-2018 |
|---|
| Recall Event ID |
80688 |
| Product Classification |
Accessories, arthroscopic - Product Code NBH
|
| Product | Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory. |
|---|
| Code Information |
Lot#M180018 |
Recalling Firm/
Manufacturer |
Ceterix Orthopedics, Inc.
6500 Kaiser Dr Ste 120
Fremont CA 94555-3662
|
| For Additional Information Contact |
650-316-8661 |
|---|
Manufacturer Reason
for Recall | Possible nonconforming blades may result in a higher than specified cut force required to cut the suture. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| Action | Ceterix Orthopaedics notified customers via an "Urgent Field Safety Notice: for NovoCut Suture Manager. The letter dated May 16, 2018 provided the following: Details on affected devices, Description of the problem, Risks to Health, Actions to be taken by the customer, and Contact reference person. |
|---|
| Quantity in Commerce | 96 units |
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| Distribution | United States distribution. |
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| 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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