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U.S. Department of Health and Human Services

Class 3 Device Recall 30 Black Mono Nylon Suture

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  Class 3 Device Recall 30 Black Mono Nylon Suture see related information
Date Initiated by Firm September 09, 2008
Date Posted October 02, 2008
Recall Status1 Terminated 3 on March 27, 2009
Recall Number Z-0034-2009
Recall Event ID 49494
510(K)Number K930825  
Product Classification Suture - Product Code GAR
Product 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
Code Information Lot number M335870
Recalling Firm/
Surgical Specialties Corp
100 Dennis Dr
Reading PA 19606
For Additional Information Contact Dave Alexander
Manufacturer Reason
for Recall
mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture
FDA Determined
Cause 2
Employee error
Action The recalling firm issued a Recall letter dated 9/9/08 to its customers. The letter informed the customers of the problem, the need to conduct a sub-recall, and return the product. Contact Surgical Specialties Corp. at 1-610-404-1000 for assistance.
Quantity in Commerce 956 boxes
Distribution USA--AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MD, MI, MS, NC, NJ, NY, OH, TN, TX, VA, and WA. OUS: Australia, Canada, and Fiji Islands.
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 = SURGICAL SPECIALTIES, INC.