Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
FDA device recall Z-0582-2014 · posted 2013-12-27 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
- Action taken
- 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
- Status
- Terminated
- Product code
- HWA
- Quantity affected
- 1,690 units
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2013-09-30
- Date posted
- 2013-12-27
- Date terminated
- 2016-10-19
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.