International Science & Technology, LP, DBA Diamatrix Ltd. 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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".

Recommended Action

Per FDA guidance

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.