—#191837

Product

Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044

FDA product code: JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K121308
Affected lot / code info: GTIN: 04546540509048; Lot G7900236

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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 strykerortho6067@sedgwick.com. 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

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: The product was distributed to the following US states: MI

Timeline

Recall initiated: 2021-12-30
Terminated: 2024-03-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191837. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.