CLASS II Device recall · Reported 21 Dec 2016 · FDA Enforcement Report

Metzenbaum Scissors 7, Curved recalled by Integra York PA

Integra York PA is recalling Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved are single-use, distributed in North Carolina, Texas. The recall was initiated on 28 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog # ST5-182; lot# 355

Quantity recalled50 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0752-2017
FDA event ID: 75710
Recalling firm: Integra York PA, York, PA
Classification: Class II
Status: Terminated
Recall initiated: 28 Oct 2016
FDA classified: 13 Dec 2016
Reported: 21 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

28 Oct 2016	Recall initiated by company
13 Dec 2016	Classified by FDA	+46 days
21 Dec 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.

Where it was distributed

US Distribution in NC and TX.

North Carolina Texas

Questions about this recall

Why was it recalled?

The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.

Which lots are affected?

Catalog # ST5-182; lot# 355

Where was it sold?

US Distribution in NC and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 75710

This product is part of a recall event; the main page for the event is Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile recalled.

Reported	Class	Recall	Company	Reason	Where
21 Dec 2016	CLASS II	Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile recalled	Integra York PA	Sterility	NC, TX

More recalls from Integra York PA

All 4

Reported	Class	Recall	Company	Reason	Where
21 Dec 2016Device	CLASS II	Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile recalled	Integra York PA	Sterility	NC, TX
8 Jun 2016Device	CLASS II	Miltex Premium Grade Self-Lock Chisel Blade Handle recalled	Integra York PA	Other	Nationwide
17 Sep 2014Device	CLASS II	Integra Container Lid, ¿¿ Size, Red recalled by Integra York PA	Integra York PA	Other	FL

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All 3,809

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