Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile; Stryker Trauma GmbH, 2432 Schonkirchen, Germany. Distributed in the US by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 007430 Reduction spoons are sold separately or as part of a kit. The Universal Rod with Reduction Spoon may be used as a fracture reduction tool to facilitate Guide Wire insertion.
FDA Recall Z-0191-2009 · Posted 2008-10-28
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-08-14
Date Terminated2012-05-29
Product Quantity1070 units
Reason for Recall
Stryker has become aware of the potential for breakage of the Reduction Spoon designed prior to 2003.
Firm Action
Recall notification letters were sent on August 14, 2008 to all branches and hospitals via Federal Express. Questions are to be directed to 201-831-5718 or a Trauma team member listed in the letter.
Root Cause
Device Design
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.