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.
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 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.
- Affected units
- 59
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:
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- ModerateHowmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls Triathlon Universal Baseplate Finishing Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Triathlon Instrument Trays Recalled for Sterilization Dry Time Issue
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls TS Femoral Prep Trays Due to Sterilization Instructions
FDA (Devices) · 2026-10-21
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
Same hazard · label mix up
See all →- HighAmphetamine extended-release capsules contain immediate-release pellets after label mix-up
FDA (Drugs) · 2026-07-08
- SevereSandoz cefazolin cartons contained vials labeled as penicillin G potassium
FDA (Drugs) · 2025-07-09
- SevereBuffered penicillin G potassium vials may actually contain cefazolin for injection
FDA (Drugs) · 2025-07-09
- ModerateEye drops recalled nationwide due to labeling mix-up
FDA (Drugs) · 2025-01-08
- HighPrescription Drug Sunitinib Malate Subject to Label Mix-Up Recall
FDA (Drugs) · 2024-12-11
Similar recalls
- ModerateHip stems recalled over potential mix of two catalog numbers in packaging
FDA (Devices) · 2025-10-08
- ModerateStryker Recalls Specific Hip Stems Due to Packaging Error
FDA (Devices) · 2014-04-09
- HighUNITRAX Hip Implant Head Component Recalled for Package Label Size Mismatch
FDA (Devices) · 2024-07-24
- HighCeramic Hip Femoral Head Component May Not Match Package Label
FDA (Devices) · 2022-04-06
- ModerateBiomet Echo Hip Stems Recalled Due to Incorrect Size Etching
FDA (Devices) · 2012-12-05
- HighHip Prosthesis Component Mislabeled; Package Size May Not Match Device
FDA (Devices) · 2024-07-24