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U.S. Department of Health and Human Services

Class 2 Device Recall Monomid NonAbsorbable Suture

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  Class 2 Device Recall Monomid NonAbsorbable Suture see related information
Date Initiated by Firm June 29, 2011
Date Posted September 09, 2011
Recall Status1 Terminated 3 on May 24, 2012
Recall Number Z-3177-2011
Recall Event ID 59759
510(K)Number K001173  
Product Classification Suture, nonabsorbable, synthetic, polyamide - Product Code GAR
Product Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes.

The products are labeled in parts.

These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological surgery.
Code Information LOT Numbers: 070205-04, 070205-05, 070221-05, 070322-04, 070410-02, 070430-08, 070517-12, 070702-03, 070726-06, 070824-04, 070924-08, 071024-05, 080103-24, 080111-02, 080211-01, 080227-09, 080424-21, 080424-22, 080424-24, 080602-18, 080825-11, 080911-05, 081002-12, 081202-02, 090211-07, 090310-14, 090415-03, 090429-07, 090515-04, 090706-10, 090803-06, 090904-02, 091110-15, 091119-07, 100114-39, 100122-05, 100305-05, 100317-11, 100505-18, 100702-05, 100706-01, 100810-08, 100921-10, 101129-19, 101208-01, B0605230, D0510140, D0610330, D0611040, G0220310, G0619440, G0619530-1, H0523640, H0622330, J0528740, J0627630-1, J0628240, L0534830, and L0635430-1.
Recalling Firm/
Manufacturer		 C P Medical Inc.
803 NE 25th Avenue
Portland OR 97232-2304
For Additional Information Contact Barbara Horton
503-232-1555
Manufacturer Reason
for Recall		 Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material.
FDA Determined
Cause 2		 Process control
Action CP Medical sent a "RECALL NOTICE" letter dated June 29, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected products in the human market and to return all their existing stock. A Recall Checklist was enclosed for customers to complete and return. Contact Customer Service at 1-800-950-2763 for a Return Good Authorization and shipping account number. The firm will pay for shipping cost and replace product at no cost to customers.
Quantity in Commerce 776 dozens boxes
Distribution Worldwide Distribution-USA (nationwide) and the countries of Italy, Romania, South Africa, and Taiwan.
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 = GAR and Original Applicant = CP MEDICAL
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