Hip Implant Stem Recalled for Failed Fatigue Testing
Corin Ltd is recalling a hip implant stem component (Model 588.3800) after some units failed fatigue testing. The affected devices were distributed to New Jersey only.
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 medical device recall where some units failed fatigue testing. Although no injuries or illnesses have been reported, a hip implant with potential structural failure presents a risk of harm to patients. This meets the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Corin Ltd is recalling the TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper with 188.550 Centraliser (Model 588.3800, Lot 494754), an orthopedic hip implant component used in hip replacement surgery.
Some of the recalled devices did not pass fatigue testing.
The recalled devices were distributed to New Jersey only. Patients who received this implant should contact their healthcare provider to verify if they are affected.
The recalled product
- Product
- TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
- Manufacturer
- Corin Ltd
- 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 (3)
- Model #588.3800
- Lot #494754
- UDI 05055343871065
Distribution
Distributed in 1 state:
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