Howmedica recalls Stryker Omnif: Crossfire 10 Degree Series II Insert for possible missing locking wire causing surgery delays or improper implantation.
“Howmedica Stryker Omnifit Crossfire 10 Degree Insert Recall: Missing Locking Wire Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66553-howmedica-stryker-omnifit-crossfire-10-degree-insert-recall-missing-locking. Based on FDA recall #Z-0811-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0811-2020%22&limit=1).
The FDA announced on 2019-11-07 that Howmedica Osteonics Corp. is recalling Stryker Omnifit Crossfire 10 Degree Series II Inserts due to a potential missing locking wire. The agency said the defect may cause surgery delays while retrieving a backup device or implanting a unit without the wire.
How to tell if you have it
Stryker Omnifit Crossfire 10 Degree Series II Insert
Catalog #: 2041C-3254
Lot Number: 53778501
UDIs: (01)04546540035806(17)201108(10)53778501
UPC: 04546540035806
The hazard
According to the FDA, the devices may have a missing locking wire. This defect can cause delays in surgery while retrieving a back-up device or implanting a device that is missing a locking wire.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since 2017-07-21. Recent brand recalls include the 2026-07-30 Howmedica SCORPIO Patella Implants Recall for oxidation risk, the 2026-05-19 Howmedica Triathlon Baseplate Size 4 Recall for confusing labeling, and the 2026-02-02 Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall for loose screws. Other recent recalls of similar products include the 2026-07-14 ConMed Suture Anchor Recall and the 2026-04-10 Stryker Daig Livewire Steerable Catheter Recalls.
How to tell if you have this one
Check for catalog number 2041C-3254 and lot number 53778501 on the implant packaging or label. The product was sold with specific UDIs: (01)04546540035806(17)201108(10)53778501.
Brand
Howmedica
Product
Stryker Omnifit Crossfire 10 Degree Series II Insert
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Implant Details
Verify the catalog number 2041C-3254 and lot number 53778501 on the implant packaging or label.
Where it went and when
Where it was distributed
Distributed in 9 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan” States read from FDA’s own wording; “not listed” means the notice does not name it.
The recall does not require immediate stop use; however, patients should check if their implant matches the recalled model and contact Howmedica for further instructions.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0811-2020 (November 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0811-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.