Z-0652-2022Class II

Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440

Name: Z-0652-2022 Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
Creator: Howmedica Osteonics Corp.
Published: 2021-12-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2021-12-30 / Terminated / root cause: labeling and UDI

FDA source

Howmedica Osteonics Corp. began a recall of Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440 on 2021-12-30. FDA classified it as Class II and gives the reason as "There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0652-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-30
Posted: 2022-02-17
Terminated: 2024-03-14
Recalling firm: Howmedica Osteonics Corp
Product: Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
Product code: JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: An URGENT MEDICAL DEVICE RECALL dated 12/30/21 was sent to customers. Actions Needed: Our records indicate that you may have received the affected product(s). It is Stryker s responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Discontinue use of the recalled Exeter V40 Cemented Hip Stems, Lots #G7900352 and #G7900236 and return the product. 4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-866-660-8956 or email to [email protected]. 5. Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 6. Branches/Agencies Only: Please forward this Urgent Medical Device Recall to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address. Att. Regina Short (Quality Manager) / PFA# 2847072 Stryker Global Quality & Operations Tullagreen Building, IDA Business & Technology Park, Carrigtwohill, Cork, Ireland T45 HE42 7. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. Under 21 CFR 803, manufacturers are also req
Quantity in commerce: 58 devices
Distribution: The product was distributed to the following US states: MI
Product codes and lots: GTIN: 04546540153296; Lot G7900352

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0652-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0651-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-23	2022-02-17
Z-0652-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-23	2022-02-17

Product code JDG

K121308Class IIHip SystemsHowmedica Osteonics Corp. / cleared 2012-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)