Omnifit EON Surgical Protocol; Literature Number: LSP48 4/04 Stryker Howmedica Osteonics Corp., Mahwah, NJ
FDA device recall Z-1750-2008 · posted 2008-08-17 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 2501 units
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, Australia, Latin America and Greece.
- Date initiated
- 2007-05-17
- Date posted
- 2008-08-17
- Date terminated
- 2008-08-19
- Location
- Mahwah, NJ
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