FDA Medical Device Recalls (openFDA)
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 number
- Z-2055-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Status
- Terminated
- Initiated
- 2005-03-09
- Posted
- 2008-09-16
- Terminated
- 2008-09-24
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- Sell sheets: 1919, Cutting Edge Advantage Brochure: 810
- Distribution
- Worldwide
- Lot, serial or model codes
- Literature number: LHFX-SS rev 1; Cutting Edge Advantage Brochure w/inserts, Literature Number: LCEA-B
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWT
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28