Howmedica recalls Stryker Omnif: Crossfire 10 Degree Series II Insert for possible missing locking wire causing surgery delays or improper implantation.
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
Howmedica is recalling Stryker Omnifit Crossfire 10 Degree Series II hip implants due to a potential missing locking wire that could delay surgery or cause improper implantation. This risk affects patients who received the specific model with the listed catalog and lot numbers.
The implant may have a missing locking wire, which could cause delays in surgery while retrieving a backup device or lead to improper implantation if the wire is missing during the procedure.
Patients who received the Stryker Omnifit Crossfire 10 Degree Series II hip implants with catalog number 2041C-3254 and lot number 53778501 are most at risk. Orthopedic surgeons and their patients using these implants during surgery are affected.
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.
Verify the catalog number 2041C-3254 and lot number 53778501 on the implant packaging or label.
The Stryker Omnifit Crossfire 10 Degree Series II Insert with catalog number 2041C-3254 and lot number 53778501.
The implant may have a missing locking wire, which could cause delays in surgery while retrieving a backup device or lead to improper implantation.
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.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0811-2020 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0811-2020 from Howmedica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.