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

Stratum MDS Screw 3.5x50mm ST recalled by Nextremity Solutions

Nextremity Solutions is recalling Stratum MDS Screw 3.5x50mm 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: M1268 UDI: 00817701023173

Quantity recalled86 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-0778-2020
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 3.5x50mm ST Part Number: STRM-MDS-3550ST

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Components 2mm shorter than indicated on the package label

Which lots are affected?

Lot Number: M1268 UDI: 00817701023173

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 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

2 other products · FDA event 84405

Reported	Class	Recall	Company	Reason	Where
15 Jan 2020	CLASS II	Stratum MDS Screw 3.5x46mm ST recalled by Nextremity Solutions	Nextremity Solutions	Packaging Defects	Nationwide
15 Jan 2020	CLASS II	Stratum MDS Screw 3.5x48mm ST recalled by Nextremity Solutions	Nextremity Solutions	Packaging Defects	Nationwide

Reported	Class	Recall	Company	Reason	Where
20 Apr 2022Device	CLASS II	Nextra Hammertoe Correction System 4.5 Middle recalled	Nextremity Solutions	Other	Nationwide
20 Apr 2022Device	CLASS II	Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit recalled	Nextremity Solutions	Other	Nationwide
20 Apr 2022Device	CLASS II	Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit recalled	Nextremity Solutions	Other	Nationwide
20 Apr 2022Device	CLASS II	Nextra Hammertoe Correction System Driver recalled	Nextremity Solutions	Other	Nationwide
20 Apr 2022Device	CLASS II	Nextra Hammertoe Correction System 3.5 Middle recalled	Nextremity Solutions	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide