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EXETER recallZ-0652-2022 · Howmedica Osteonics Corp. · initiated Dec 30, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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

Recall details

Recall number
Z-0652-2022
Status
Terminated
Initiated by the company
Dec 30, 2021
Recalling firm
Howmedica Osteonics Corp.
Quantity
58 devices
Product code
JDG
FDA submissions
K121308
Distribution
The product was distributed to the following US states: MI

Product description

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

Code information (models, lots, serial numbers)

GTIN: 04546540153296; Lot G7900352

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 89520).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page