Class 2 Device Recall HemoLokSMX Legating Clip

• Date Initiated by Firm: January 23, 2004
• Date Posted: February 25, 2004
• Recall Status: Terminated on May 11, 2004
• Recall Number: Z-0547-04
• Recall Event ID: 28248
• 510(K)Number: K982941
• Product Classification: Clip, Implantable - Product Code FZP
• Product: Hem-o-Lok¿SMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck Closure Systems¿, Research Triangle Park, NC 27709, Sterile, Single use, Disposable.
• Code Information: Catalog number 544220, Lot number 988384
• Recalling Firm/ Manufacturer: Weck; 1 Weck Dr.; Research Triangle Park NC 27709
• For Additional Information Contact: 919-361-4034
• Manufacturer Reason for Recall: Malformation of the Hem-o-lok SMX clip.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter via Federal Express (Domestic consignees), Email (International and Weck Sales Representatives), and Fax (Weck Sales Representatives) beginning 01/23/2004.
• Quantity in Commerce: 70 sales units
• Distribution: Distributors and hospitals in AL, CA, FL, MA, MD, MI, NC, NY, OH, OR, PA, SC, TX, Korea and France
• 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 = FZP and Original Applicant = WECK CLOSURE SYSTEMS