The Recall Desk
HighFDA (Devices)·Z-0652-2022·Announced 2022-02-23

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.

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 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.
Category
Medical Device — Orthopedic / Hip Prosthesis
Hazard
  • mis-labeling
  • 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: 04546540153296
  • Lot G7900352

Distribution

Distributed in 1 state:

  • MI

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