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Omnifit recallZ-0811-2020 · Howmedica Osteonics Corp. · initiated Nov 7, 2019

Class II 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

May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire

FDA root cause category: Employee error

What the company is doing

Stryker issued Urgent Medical Device Recall - PFA 2147264 letter dated November 7, 2019) to US consignees by third-party recall company, Stericycle Inc. (2670 Executive Drive Indianapolis, IN 46241), via UPS 2nd day air. Letter states reason for recall, health risk and action to take: Actions Needed: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 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. A response is required, even though you may not have any physical inventory on site anymore. 3.Quarantine and discontinue use of the recalled devices. 4.Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-350-3903 or email to [email protected] within 5 Days. 5.Hospitals Only: Return all affected product available at your location to your local branch office. 6.Branches/Agencies: Return all affected product returned by the hospital and/or 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, PFA #2147264. Actions Needed: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization.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. A response is required, even though you may not have any physical inventory on site anymore. 3.Quarantine and discontinue use of the recalled devices. 4.Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to

Recall details

Recall number
Z-0811-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 7, 2019
Recalling firm
Howmedica Osteonics Corp.
Quantity
20 units
Product code
JDI
FDA submissions
K974685
Distribution
CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan

Product description

Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254

Code information (models, lots, serial numbers)

Lot Number: 53778501 UDIs: (01)04546540035806(17)201108(10)53778501

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

12 devices cleared under K974685 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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