CLASS II Device recall · Reported 22 Jan 2020 · FDA Enforcement Report

Stryker Omnifit Crossfire 10 Degree Series II Insert recalled

Howmedica Osteonics is recalling Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or, distributed in 9 states. The recall was initiated on 7 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 53778501 UDIs: (01)04546540035806(17)201108(10)53778501

Quantity recalled20 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0811-2020
FDA event ID: 84346
Recalling firm: Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 7 Nov 2019
FDA classified: 15 Jan 2020
Reported: 22 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

7 Nov 2019	Recall initiated by company
15 Jan 2020	Classified by FDA	+69 days
22 Jan 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan

California Florida Georgia Iowa Massachusetts Michigan North Carolina Ohio Wisconsin

Questions about this recall

Why was it 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

Which lots are affected?

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

Where was it sold?

CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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