Class 2 Device Recall ProTekt Sharps Safety Knives

• Date Initiated by Firm: February 24, 2022
• Create Date: May 20, 2022
• Recall Status: Completed
• Recall Number: Z-1120-2022
• Recall Event ID: 89827
• Product Classification: Knife, ophthalmic - Product Code HNN
• Product: Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel
• Code Information: Item # PG 44620MU; Lot # : B923LUC
• Recalling Firm/ Manufacturer: International Science & Technology, LP, DBA Diamatrix Ltd.; 210 Nursery Rd; Spring TX 77380-1943
• For Additional Information Contact: Dominique Armstrong; 800-537-8081 Ext. 4
• Manufacturer Reason for Recall: Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of "2.5mm" when the actual size is "2.2mm".
• FDA Determined Cause: Labeling Change Control
• Action: Between the dates of February 16, 2022 - March 10, 2022, Diamatrix Ltd. issued a "Urgent: Medical Device Recall Notification. In addition to notifying consignees about the recalled product, the firm asked consignees to take the following actions: " Discontinue or do not use Diamatrix Item # PG 44620MU ProTekt 2.2mm Double Bevel Slit knives from Lot B923LUC. " Return the product to Diamatrix immediately. Please contact our customer service, 800-867-8081, to obtain a shipping label from Diamatrix. " Acknowledge this Voluntary Recall by returning the included Medical Device Recall Return Response letter within 3 business days of receiving this Recall letter. " A complimentary phone call to the phone numbers mentioned below would assist us with immediate tracking and reports to the FDA.
• Quantity in Commerce: 90 units
• Distribution: Worldwide distribution - US Nationwide distribution in the states of MN, TX and the country of Germany.
• 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.