Stanmore Distal Femoral Replacement Recalled for Incorrect Component
Stanmore Implants Worldwide Ltd. is recalling one custom-made distal femoral replacement implant due to the use of an incorrect component during manufacturing.
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: The recall involves a medical device with a manufacturing defect (incorrect component) that poses a risk of harm, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Stanmore Implants Worldwide Ltd. is recalling one unit of a patient-specific, custom-made distal femoral replacement implant. The recall was initiated because an incorrect component was used to manufacture the device.
The affected product is identified by Device Identifier PIN 19960 and Lot 19960. The device was distributed in the United States to Ohio.
Consumers and healthcare providers who have this specific implant should contact the recalling firm for further instructions on how to proceed.
The recalled product
- Product
- Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
- Manufacturer
- Stanmore Implants Worldwide Ltd.
- Hazard
- Affected units
- 1
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)
- Device Identifier: PIN 19960
- Lot: 19960
Distribution
Distributed in 1 state:
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