—#70091

Product

Omnifit EON Surgical Protocol; Literature Number: LSP48 4/04 Stryker Howmedica Osteonics Corp., Mahwah, NJ

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Literatur Number LSP48 4/04

Why it was recalled

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 (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of Canada, Australia, Latin America and Greece.

Timeline

Recall initiated: 2007-05-17
Posted by FDA: 2008-08-17
Terminated: 2008-08-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70091. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.