CLASS II ONGOING Device recall · Reported 9 Mar 2022 · FDA Enforcement Report

Everest MI XT Outer Dilator recalled by K2M

K2M is recalling Everest MI XT Outer Dilator, distributed nationwide in the US. The recall was initiated on 13 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN

Quantity recalled686 Total Devices

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-0706-2022
FDA event ID: 89522
Recalling firm: K2M, Leesburg, VA
Classification: Class II
Status: Ongoing
Recall initiated: 13 Jan 2022
FDA classified: 1 Mar 2022
Reported: 9 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Jan 2022	Recall initiated by company
1 Mar 2022	Classified by FDA	+47 days
9 Mar 2022	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

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

Product as listed by the FDA

Everest MI XT Outer Dilator, Catalog Number 5101-90168

Where it was distributed

Worldwide distribution - US Nationwide.

Nationwide

Questions about this recall

Is Everest MI XT Outer Dilator recalled?

Yes. K2M recalled Everest MI XT Outer Dilator on 13 Jan 2022. The recall is Class II and its status is Ongoing. Recall number Z-0706-2022.

Why was it recalled?

Which lots are affected?

GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN

Where was it sold?

Worldwide distribution - US 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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