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U.S. Department of Health and Human Services

Class 2 Device Recall Suture cutter

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  Class 2 Device Recall Suture cutter see related information
Date Initiated by Firm October 13, 2015
Date Posted November 09, 2015
Recall Status1 Terminated 3 on February 12, 2016
Recall Number Z-0250-2016
Recall Event ID 72500
Product Classification Accessories,arthroscopic - Product Code NBH
Product NovoCut Suture Manager; Ceterix catalog number CTX-001.

General and Plastic Surgery: Intended for use in arthroscopic surgery.
Code Information Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239.
Recalling Firm/
Manufacturer		 Ceterix Orthopedics, Inc.
959 Hamilton Ave
Menlo Park CA 94025-1431
For Additional Information Contact Scott King
650-396-3478
Manufacturer Reason
for Recall		 The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
FDA Determined
Cause 2		 Device Design
Action Ceterix Orthopaedics sent an Urgent Field Safety notification letter dated October 13, 2015, to all affected sites. The product was identified, reason for recall explained and letter contains list of product lot numbers affected. Customers were instructed to identify and quarantine the affected product, contact Ceterix Orthopaedics to arrange a no cost return, and complete and return the attached acknowledgement form. Customers with questions were instructed to call 1-888-305-0615 or email: docs@ceterix.com. For questions regarding this recall call 650-396-3478.
Quantity in Commerce 1364 units
Distribution Nationwide Distribution
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.
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