Exeter V40 Cemented Hip Stem Labels May Mismatch Between Sizes
The FDA has recalled Exeter V40 Cemented Hip (150mm) Stems due to a potential labeling mix-up with the 125mm version. Patients who received the device should verify with their surgeon that the correct size was implanted.
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 involving a labeling error on a surgical implant. While no illnesses or injuries have been reported, the mix-up of implant sizes poses a risk-of-harm situation requiring intervention.
Plain-English summary
Howmedica Osteonics Corp. is recalling certain lots of the Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440. There is a potential labeling mix-up between this product and the 125mm variant.
The recall was issued because of the risk that the wrong label could be on the implant, potentially resulting in the wrong-sized device being used during hip replacement surgery.
Fifty-eight devices from lot G7900352 were distributed to Michigan. Patients who received this implant should contact their surgeon to verify that the correct size was implanted.
The recalled product
- Product
- Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 58
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: 04546540153296
- Lot G7900352
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Howmedica Osteonics Corp. 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.
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