Class 2 Device Recall Knife, Opthalmic

• Date Initiated by Firm: February 28, 2011
• Date Posted: April 05, 2011
• Recall Status: Terminated on June 14, 2012
• Recall Number: Z-1894-2011
• Recall Event ID: 58109
• Product Classification: Knife, Opthalmic - Product Code H--NN
• Product: BD Beaver XStar Safety 2.5mm Crescent Knife;; REF 378234; Crescent blades are used in a variety of ophthalmic surgery. Product is a cataract surgery knife designed for optimal tunnel architecture.
• Code Information: Lot/serial number: 0333798
• Recalling Firm/ Manufacturer: Beaver-Visitec International Inc.; 411 Waverley Oaks Rd Ste 229; Waltham MA 02452-8422
• For Additional Information Contact: Steven Bourdon; 781-906-7917
• Manufacturer Reason for Recall: Loose blades in the handle of knives due to uncured epoxy.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Beaver Visitec International, Inc.sent an Urgent Recall Notification letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product and to complete a Customer Response Form (to be returned via fax to 866-906-4304. For questions regarding this recall call 781-906-7917.
• Quantity in Commerce: 1680 units (1130 domestic, 550 foreign)
• Distribution: Worldwide Distribution - USA including AZ, MA, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, VA and the country of China

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.