Stryker Howmedica Osteonics Corp. OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Literature number: LHFX-SS rev 1, Cutting Edge Advantage Brochure w/inserts, Literature Number: LCEA-B
Products Sold
Literature number: LHFX-SS rev 1; Cutting Edge Advantage Brochure w/inserts, Literature Number: LCEA-B
Stryker Howmedica Osteonics Corp. is recalling OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide due to The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sl. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems.
Recommended Action
Per FDA guidance
Notification letters and Product Accountability Forms were sent to consignees via Fed-ex on March 9, 2005 with return receipt. An advisory notice was sent to Canada and International distributors on March 9, 2005. For information on this recall, contact Rita Intorrella at 201-831-5825 or Greg Schack at 201-831-5399.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026