Device Recall Weck

Product Code: 523300, Lot number: 01B1400034

General and Plastic Surgery Devices

2

Yes

US (nationwide) including the states of AL, CA, FL, DE, IA, IL, IN, KY, MA, MN, NC, NE, NJ, NY, NV, OH, OK, PA, TX, VA, VT, and WA.

WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. || Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.

Product Code EFXCT1 - Lot/Batch Nos. ML-000342, ML-000343, ML-000344, ML-000348, ML-000349; Product Code EFXSP1 - Lot/Batch Nos. ML-000345, ML-000347

General and Plastic Surgery Devices

1

No

Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA

Weck EFx Classic Fascial Closure System, Rx Only, Sterile, || The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

Product Code: 337111, Lot Number: 06F1515745.

General and Plastic Surgery Devices

1

No

Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.

WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, || Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge for which it is to be used. Hemoclip Plus appliers are easily identified by one black-ring handle.

Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.

General and Plastic Surgery Devices

1

No

Domestic; US Nationwide; International: Belgium, Canada.

Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

Product Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.

General and Plastic Surgery Devices

1

No

Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.

WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. || The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures.