The Recall Desk
HighFDA (Devices)·Z-1851-2021·Announced 2021-06-23

Hip prosthesis components recalled for mislabeling with incorrect sizes and types

Corin TriFit hip prosthesis components from lot 467881 were mislabeled, with size 2 stems labeled as size 7 and vice versa. Surgeons could implant incorrect components during hip replacement surgery.

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 recall involving significant labeling errors on hip prosthesis components that could result in incorrect surgical implantation. While no illnesses or injuries have been reported, the risk-of-harm nature of implanting mismatched prosthesis components justifies a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Corin Ltd is recalling TriFit hip prosthesis components from lot 467881 due to a labeling error. Units from one batch were mislabeled: some TriFit TS size 2 stems were incorrectly labeled as TriFit CF size 7 components, and some size 7 components were labeled as size 2 stems.

This labeling error could result in surgeons receiving and implanting prosthesis components that do not match what was ordered or intended for a specific patient's hip replacement surgery.

The recalled components were distributed nationwide. No illnesses or injuries have been reported in connection with this labeling error. Patients who have undergone hip replacement surgery and healthcare providers should review their records and consult with Corin Ltd regarding any components from this lot.

The recalled product

Product
Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.
Manufacturer
Corin Ltd
Category
Medical Device — Orthopedic / Hip Prosthesis
Hazard
  • mis-labeling
  • device-mismatch

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)

  • Lot Number 467881

Distribution

Distributed nationwide across the United States.

Related recalls

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