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V40 Head recallZ-0314-2022 · Howmedica Osteonics Corp. · initiated Oct 15, 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 white Tyvek lid to debond from the sealed package.

FDA root cause category: Under Investigation by firm

What the company is doing

On 10/15/2021, Stryker issued Urgent Medical Device Recall notices to customers. Actions Needed: 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. Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form 5. Hospitals Only: 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 to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2812588

Recall details

Recall number
Z-0314-2022
Status
Open, Classified
Initiated by the company
Oct 15, 2021
Recalling firm
Howmedica Osteonics Corp.
Product code
JDG
FDA submissions
K173499
Distribution
Puerto Rico

Product description

28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122

Code information (models, lots, serial numbers)

UDI number - (01) 07613327013016(17)261013(10); lot numbers - 86604305, 86604306

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

20 devices cleared under K173499 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88964).

Sources and updates

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