Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
Summary
The FDA issued a Class II for Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 by Howmedica Osteonics Corp.. Reason: There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem..
Details
Source
Device Recall
External ID
Z-0651-2022
Action Date
2022-02-23
Status
Terminated
Category
device
Product Description
Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
Lot/Code Info: GTIN: 04546540509048; Lot G7900236
Quantity Affected: 59 devices
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.
Distribution
The product was distributed to the following US states: MI
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-30
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Howmedica Osteonics Corp. has 113 FDA actions in our database, including 113 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Howmedica Osteonics Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Howmedica Osteonics Corp. have FDA actions?
Howmedica Osteonics Corp. has 113 FDA actions in our database, including 113 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0651-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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