Exeter V40 Cemented Hip Stem Recalled for Potential Label Mix-Up
Howmedica Osteonics is recalling Exeter V40 Cemented Hip (125mm) Stem devices due to a potential label mix with 150mm stems. Incorrect labeling could result in wrong implant size being used during 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: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is a labeling error that could result in wrong-size surgical implant, representing a risk-of-harm product, but no actual harm has been reported to date.
Plain-English summary
Howmedica Osteonics Corp. is recalling Exeter V40 Cemented Hip (125mm) Stem devices (Part Number 0580-1-044, Lot G7900236) due to a potential label mix with Exeter V40 Cemented Hip (150mm) Stem devices. The issue involves incorrect labeling that could result in surgeons implanting the wrong stem size.
If a patient receives a cemented hip stem that does not match the size intended by the surgeon, it could lead to poor surgical outcomes, including improper implant positioning and inadequate function.
The recalled product was distributed to Michigan. A total of 59 devices are affected by this recall. Patients who have received this implant should contact their healthcare provider to determine if their implant was part of this recall and whether follow-up evaluation is necessary.
The recalled product
- Product
- Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- label-mix-up
- implant-size-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 (2)
- GTIN: 04546540509048
- Lot G7900236
Distribution
Distributed in 1 state:
- MI
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