The Recall Desk
HighFDA (Devices)·Z-0706-2022·Announced 2022-03-09

K2M Everest MI XT Outer Dilators recalled for manufacturing defect

K2M is recalling 686 Everest MI XT Outer Dilator units due to a manufacturing nonconformance that prevents them from fitting properly with inner dilators during surgical procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a manufacturing nonconformance affecting device assembly during surgical procedures. No hospitalizations or injuries are reported in the source, but the potential for surgical complications from device failure warrants high severity.

Plain-English summary

K2M, Inc. is recalling 686 Everest MI XT Outer Dilator units (Catalog Number 5101-90168) worldwide due to a manufacturing nonconformance.

Stryker reported receiving two complaints that the affected dilators do not fit together properly with inner dilators during surgical procedures. Investigation determined that units from multiple lots are affected by this manufacturing defect.

Healthcare facilities, physicians, and patients should stop using units from the affected lots immediately. Contact K2M for replacement guidance. Affected lot numbers are HCBN, HCBP, JUJJ, KFMX, KUPH, KYYV, MDPF, NAKJ, NDGT, and PCCN.

The recalled product

Product
Everest MI XT Outer Dilator, Catalog Number 5101-90168
Manufacturer
K2M, Inc
Category
Medical Device — Surgical Instrument
Hazard
  • assembly-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category