FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Omnifit EON Surgical Protocol; Literature Number: LSP48 4/04 Stryker Howmedica Osteonics Corp., Mahwah, NJ
- Recall number
- Z-1750-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Omnifit EON Surgical Protocol; Literature Number: LSP48 4/04 Stryker Howmedica Osteonics Corp., Mahwah, NJ
- Status
- Terminated
- Initiated
- 2007-05-17
- Posted
- 2008-08-17
- Terminated
- 2008-08-19
- Reason
- The Table 2 Broach and Neck Trial Sizing (Literature # LSP48 04/04) on page 3 is incorrect, reading 5mm less than what it should be for certain sizes.
- Root cause
- Labeling design
- Action
- Styrker Branches/Agencies were notified of the incorrect information printed in the protocal on May 17, 2007 via an Important Product Correction letter. The letter requested that all incorrect copies of the protocol be located and destroyed immediately. They requested that the Acknowledgement Form be completed and faxed, and that a Stryker Orthopaedics Customer Service rep be contacted in order to reorder the destroyed product.
- Quantity
- 2501 units
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, Australia, Latin America and Greece.
- Lot, serial or model codes
- Literatur Number LSP48 4/04
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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