CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report

Econo Sterile medical procedure kits labeled as recalled

Sklar Instruments is recalling Econo Sterile medical procedure kits labeled as: Econo Sterile Lempert Bone Rong 6.25", distributed nationwide in the US. The recall was initiated on 3 Dec 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes96-4780A, UDI/DI 50649111488021, Lot codes: HSI
Quantity recalled0 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-0952-2025
FDA event ID
95946
Recalling firm
Sklar Instruments, West Chester, PA
Classification
Class II
Status
Ongoing
Recall initiated
3 Dec 2024
FDA classified
16 Jan 2025
Reported
22 Jan 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

3 Dec 2024Recall initiated by company
16 Jan 2025Classified by FDA+44 days
22 Jan 2025Published in enforcement report+6 days

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

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

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

ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery

Where it was distributed

Domestic: Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Reports of various packaging issues that may result in a breach of the sterile barrier.

Which lots are affected?

96-4780A, UDI/DI 50649111488021, Lot codes: HSI

Where was it sold?

Domestic: Nationwide Distribution

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

29 other products · FDA event 95946

This product is part of a recall event; the main page for the event is Econo Sterile medical procedure kits labeled as recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIMedical procedure kits labeled as recalled by Sklar InstrumentsSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
CLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide

More recalls from Sklar Instruments

All 30
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
DeviceCLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
DeviceCLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
DeviceCLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide
DeviceCLASS IIEcono Sterile medical procedure kits labeled as recalledSklar InstrumentsSterilityNationwide

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