The Recall Desk
HighFDA (Devices)·Z-0237-2022·Announced 2021-11-24

Hip implant stem missing surface treatment affecting seven units

OmniLife Science is recalling 7 units of the OMNI K2 Hip Stem due to missing grit blasting on the proximal surface, a defect that could lead to implant loosening and revision surgery. The recall affects units distributed to Colorado and Virginia.

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 medical device without reported adverse events or hospitalizations. The manufacturing defect presents a theoretical risk of implant failure requiring revision surgery. Per the rubric, recalls with theoretical hazards and no reported illnesses score at most 3 (High).

Plain-English summary

OmniLife Science is recalling 7 units of the OMNI K2 Hip Stem (product code 130006, lot 38933) due to a manufacturing defect. The affected implants are missing grit blasting on the proximal surface, a critical surface treatment required for proper fixation in uncemented hip replacement procedures.

The grit blasting is essential for bone integration in uncemented hip stems. Without this surface treatment, the implant may not achieve adequate fixation and could lead to undersizing or loosening, potentially requiring revision surgery to replace the failed component.

The affected implants were distributed to hospitals and medical facilities in Colorado and Virginia. Surgeons and implant coordinators should verify the lot number (38933) of any OMNI K2 Hip Stem units in inventory. Patients who have already received this implant should contact their surgeon if they experience hip pain, instability, or unusual symptoms.

OmniLife Science is working with healthcare providers to identify and quarantine affected units. No adverse events have been reported in connection with this defect. Patients with questions should contact OmniLife Science or their surgical provider.

The recalled product

Product
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
Manufacturer
OmniLife Science
Category
Medical Device — Orthopedic Implant
Hazard
  • manufacturing-defect
  • implant-failure

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 (1)

  • UDI 00841690102496 Lot 38933

Distribution

Distribution scope not specified by the agency.

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