FDAClass IIJanuary 22, 2020

Stryker Omnifit Crossfire 10 Degree Series II Insert recall

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

Why was Stryker Omnifit Crossfire 10 Degree Series II Insert 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #…
Recalling firm
Howmedica Osteonics Corp.
Quantity
20 units
Distribution
CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan
Recall date
January 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls