Recall Z-0583-2014— Stryker Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2013-09-30, terminated 2016-10-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.. Reason: Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments..
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-30
- Terminated
- 2016-10-19
- Firm location
- Mahwah, NJ, United States
Product description
Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
Reason for recall
Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
Data sourced from openFDA. This site is unofficial and independent of the FDA.