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U.S. Department of Health and Human Services

Class 3 Device Recall Stylus 20 Polyviolene Double Armed with T Taper needles

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  Class 3 Device Recall Stylus 20 Polyviolene Double Armed with T Taper needles see related information
Date Initiated by Firm August 25, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on August 19, 2004
Recall Number Z-0936-04
Recall Event ID 27486
Product Classification Suture, Nonabsorbable, Synthetic, Polyethylene - Product Code GAT
Product Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed)
Code Information Model number DB513, Lot number M384030 exp. 7/08
Recalling Firm/
Manufacturer		 Surgical Specialties Corp
100 Dennis Dr
Reading PA 19606-3776
For Additional Information Contact Judith A. Bradley
800-523-3332 Ext. 2218
Manufacturer Reason
for Recall		 sterilization method incorrect
FDA Determined
Cause 2		 Other
Action The only customer was notified via email on 8/26/03 that the product was subject to a recall and needed to be returned.
Quantity in Commerce 2 boxes
Distribution The product was shipped to a wholesaler in Japan.
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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