Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
FDA Recall Z-0583-2014 · Posted 2013-12-27
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHWA
Date Initiated2013-09-30
Date Terminated2016-10-19
Product Quantity1,024 units
Reason for Recall
Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
Firm Action
Stryker sent an Urgent Medical Device Correction letter dated October 1, 2013 to all affected customers via Fed Ex. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and fax the attached Product Correction Acknowledgement form to 855-251-3635.
Root Cause
Device Design
Distribution Pattern
USA Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.