CLASS II Device recall · Reported 23 Feb 2022 · FDA Enforcement Report
Exeter V40 Cemented Hip Stem recalled by Howmedica Osteonics
Howmedica Osteonics is recalling Exeter V40 Cemented Hip Stem, distributed in Michigan. The recall was initiated on 30 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0651-2022
- FDA event ID
- 89520
- Recalling firm
- Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Dec 2021
- FDA classified
- 17 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 30 Dec 2021 | Recall initiated by company | |
| 17 Feb 2022 | Classified by FDA | +49 days |
| 23 Feb 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
Product as listed by the FDA
Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
Where it was distributed
The product was distributed to the following US states: MI
Questions about this recall
Is Exeter V40 Cemented Hip Stem recalled?
Yes. Howmedica Osteonics recalled Exeter V40 Cemented Hip Stem on 30 Dec 2021. The recall is Class II and its status is Terminated. Recall number Z-0651-2022.
Why was it recalled?
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
Which lots are affected?
GTIN: 04546540509048; Lot G7900236
Where was it sold?
The product was distributed to the following US states: MI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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