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Dall-Miles recallZ-0645-2022 · Howmedica Osteonics Corp. · initiated Dec 21, 2021

Open, Classified

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 for the outer Tyvek lid to de-bond from the sealed package.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT MEDICAL DEVICE RECALL UPDATE notification letter dated 12/21/21 was sent to customers. Recommendations for Patient Follow-Up Patients should continue to be followed per the normal protocol established by his/her surgeon. There are no recommended changes to the frequency of the standard follow-up care protocol. 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 important follow up 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 UPDATE 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. Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4. Complete and sign the enclosed Urgent Medical Device Recall UPDATE Business Reply Form 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 6. Please forward this Urgent Medical Device Recall UPDATE 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# 2812588 Stryker Global Quality & Operations Tullagreen Building, IDA Business & Technology Park, Carrigtwohill, Cork, Ireland T45 HE42 Please assist us in meeting our regulatory obligation by faxing back the attached Urgent Medical Device Recall UPDATE Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. We regret any

Recall details

Recall number
Z-0645-2022
Status
Open, Classified
Initiated by the company
Dec 21, 2021
Recalling firm
Howmedica Osteonics Corp.
Quantity
1 unit
Product code
KTT
FDA submissions
K872224
Distribution
Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.

Product description

Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110

Code information (models, lots, serial numbers)

UDI: 07613327013306; Lot Number: 87458602

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 89456).

Sources and updates

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