The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1850-2021·Announced 2021-06-23

Hip Prosthesis Stems Mislabeled with Incorrect Size Designation

Corin Ltd is recalling TriIFit TS size 2 hip prosthesis stems that were labeled incorrectly as TriFit CF size 7 stems, and vice versa. Patients receiving mismatched implants face risk of poor fit and potential complications.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II recall of a mislabeled medical device. Although no illnesses or injuries have been reported, a mislabeled prosthesis is a risk-of-harm product where patients could receive the wrong size implant during surgery, creating potential for serious complications.

Plain-English summary

Corin Ltd is recalling a batch of TriIFit TS SIZE 2 hip prosthesis components (Reference 694.0002, Lot 465498) due to labeling errors. Units from this batch were found to be labeled as TriFit CF size 7 stems instead of the correct TriFit TS size 2, and conversely, TriFit CF size 7 stems were labeled as TriFit TS size 2.

The labeling error creates a risk that patients may receive the wrong prosthesis size during surgical implantation. A mismatched implant could result in poor fit, instability, and potential complications requiring revision surgery.

The affected batch includes 4 units distributed nationwide in Texas. Patients who have received implants from this batch, or medical facilities with inventory from Lot 465498, should verify the actual product matches the label and contact Corin Ltd or their healthcare provider if there is any discrepancy.

Corin Ltd is the recalling manufacturer. Patients with concerns should contact their surgeon or healthcare provider immediately.

The recalled product

Product
Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Manufacturer
Corin Ltd
Category
Medical Device — Hip Prosthesis
Hazard
Affected units
4

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 465498

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Corin Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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