Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Completed

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

FDA Recall Z-1120-2022 · Posted None

Recall StatusCompleted
Product CodeHNN
Date Initiated2022-02-24
Product Quantity90 units

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".

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of MN, TX and the country of Germany.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑