Recall Z-0582-2014— 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 Rim Impactor Tip Product Usage: Used for MDM 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 Rim Impactor Tip Product Usage: Used for MDM 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.