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 MonoDox Synthetic Absorbable Suture

  • 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 MonoDox Synthetic Absorbable Suture see related information
Date Initiated by Firm January 02, 2009
Date Posted November 19, 2011
Recall Status1 Terminated 3 on December 13, 2011
Recall Number Z-0259-2012
Recall Event ID 60173
510(K)Number K013274  
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
Product Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. The product is boxed and shrink wrapped for protection against contamination. The product is a Violet, monofilament synthetic absorbable suture with needle, size 4/0 (1.5 Metric), NFS-2 Needle (Product code M397-Polydioxanone) or size 3/0 (2.0 Metric) (Product code M398 {Butler code 029254}).
Product is labeled in part: "***POLYDIOANONE Violet (PDO) Monofilament Absorbable Suture***".

Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. The suture is not recommended for adult cardiac tissue, microsurgery or neural tissue. The absorbable sutures are useful where extended wound support is desirable.
Code Information M397, M398 (Butler code 029254)
Recalling Firm/
Manufacturer		 C P Medical Inc.
803 NE 25th Avenue
Portland OR 97232-2304
For Additional Information Contact Barbara Keller Horton
503-232-1555
Manufacturer Reason
for Recall		 The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action CP Medical, Inc. sent a "RECALL NOTICE" letter dated January 5, 2009 to all affected customers.The letter describes the product, problem, and the actions to be taken by the customers. Customers are instructed to identify affected product and to return the product to the firm. Customers should call 1-503-232-1555 for a return goods authorization number and shipping account number. Contact your customer service representative at 1-800-950-2763 for questions concerning this recall.
Quantity in Commerce 13632 sutures
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.
510(K) Database 510(K)s with Product Code = NEW and Original Applicant = CP MEDICAL
-
-