MetaFix hip stem mislabeled with wrong size and batch information
A Corin MetaFix hip stem (size 7 collarless) was incorrectly labeled as a size 3 collared stem with wrong batch information. The labeling error creates risk during surgical implantation.
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 device recall involving a significant labeling error on a surgical implant. While no injuries or deaths have been reported, the mislabeling of a hip stem with incorrect size and type information poses a high risk of harm during surgical implantation, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Corin Ltd has recalled one MetaFix hip stem that was incorrectly labeled. The device is a size 7 collarless stem from batch 478179, but it was labeled as a size 3 collared stem from batch 485630.
The mislabeling of this hip stem creates a risk during surgical implantation. If a surgeon relied on the label rather than verifying the actual product received, the wrong size and type of implant could be placed, potentially requiring revision surgery.
The device was distributed in the United States, specifically in Oklahoma, Texas, and Florida. Patients who may have been affected should consult their healthcare provider if they have concerns about their hip implant.
The recalled product
- Product
- Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
- Manufacturer
- Corin Ltd
- Hazard
- Affected units
- 5
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)
- UDI (01) 0 505563 89123 0 (10) 485630 (17) 261114
- Lot Number 485630
Distribution
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