Z-1120-2022Class II

Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double...

Name: Z-1120-2022 Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double...
Creator: International Science & Technology, LP, DBA Diamatrix Ltd.
Published: 2022-02-24
License: https://open.fda.gov/license/

International Science and Technology, LP / initiated 2022-02-24 / Completed / root cause: labeling and UDI

FDA source

International Science & Technology, LP, DBA Diamatrix Ltd. began a recall of Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging... on 2022-02-24. FDA classified it as Class II and gives the reason as "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"". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1120-2022
Classification: Class II
Status: Completed
Initiated: 2022-02-24
Posted: 2022-05-20
Recalling firm: International Science and Technology, LP
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
Product code: HNN Knife, Ophthalmic
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".
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: Item # PG 44620MU; Lot # : B923LUC

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1120-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1120-2022	Class II	Completed	Voluntary: Firm initiated	2022-06-01	2022-05-20

Product code HNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)