Class 2 Device Recall Surgical Clamp Inserts

• Date Initiated by Firm: March 07, 2011
• Date Posted: August 11, 2011
• Recall Status: Terminated on March 26, 2012
• Recall Number: Z-3006-2011
• Recall Event ID: 59416
• 510(K)Number: K883790
• Product Classification: Clamp, vascular - Product Code DXC
• Product: Surgical Clamp Inserts, Model#G-8655, 86MM Insert Fibra/Fibra 15/Bx Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are available in 33, 45, 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws.
• Code Information: 1115314, 1119397, 1122010, 1122067, 1127490, 1129502, 1130375
• Recalling Firm/ Manufacturer: Applied Medical Resources Corp; 22872 Avenida Empresa # 3; Rancho Santa Margarita CA 92688-2650
• For Additional Information Contact: 949-713-8000
• Manufacturer Reason for Recall: The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers: G-8600, G-8650, G-8655, has the potential packaging nonconformance which could result in a compromise to the sterile barrier.
• FDA Determined Cause: Other
• Action: The firm, Applied Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 11, 2011 to its customers. The letter provides customers with an explanation of the problem identified and actions to be taken. The customers were instructed to check their inventory; complete and return the attached Voluntary Recall Notification Confirmation Form via fax to Regulatory Affairs at 949-713-8832, and return the recalled Standard 86mm Inserts immediately to Applied Medical, Attn: RGA# 60308783, 22872 Avenida Empresa, Rancho Santa Margarita, CA 92688. Customers with product return questions, were instructed to contact the Sales Operations Administrator, at (949) 713-8652 or by email at cjacobson@appliedmedical.com. Customers with regulatory questions, were instructed to contact the Director, Regulatory Affairs, at (949) 713-8041 or by e-mail at sfehrenbacher@appliedmedical.com.
• Quantity in Commerce: 20,247 units total
• Distribution: Worldwide distribution: USA (nationwide) including states of: Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, and Michigan; and countries of: Japan, Israel, and Singapore.
• 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 = DXC