CLASS II Device recall · Reported 15 Jan 2020 · FDA Enforcement Report

Stratum MDS Screw 5x46mm ST recalled by Nextremity Solutions

Nextremity Solutions is recalling Stratum MDS Screw 5x46mm ST, distributed nationwide in the US. The recall was initiated on 11 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: M1266 UDI: 00817701023159

Quantity recalled87 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-0776-2020
FDA event ID: 84405
Recalling firm: Nextremity Solutions, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 11 Nov 2019
FDA classified: 3 Jan 2020
Reported: 15 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

11 Nov 2019	Recall initiated by company
3 Jan 2020	Classified by FDA	+53 days
15 Jan 2020	Published in enforcement report	+12 days

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

Reason for recall

Components 2mm shorter than indicated on the package label

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST

Where it was distributed

Nationwide

Questions about this recall

Is Stratum MDS Screw 5x46mm ST recalled?

Yes. Nextremity Solutions recalled Stratum MDS Screw 5x46mm ST on 11 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-0776-2020.

Why was it recalled?

Components 2mm shorter than indicated on the package label

Which lots are affected?

Lot Number: M1266 UDI: 00817701023159

Where was it sold?

Nationwide

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

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