Food, drugs, devices › Howmedica Osteonics Corp.
Device recall: Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepar
Howmedica Osteonics Corp. (Mahwah, NJ) initiated this device recall on 7 Nov 2019; FDA lists 1 product record under event 84346, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 31 Aug 2020. Initiation: voluntary: firm initiated. Howmedica Osteonics Corp. has 48 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Howmedica Osteonics Corp., Mahwah, NJ.
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"
Distribution
"CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0811-2020 | Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254 | 20 units | Class II | Terminated | 22 Jan 2020 |
Context
Other enforcement events for Howmedica Osteonics Corp.
All 48 events for Howmedica Osteonics Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.