Recall Z-0964-2014— Stryker Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2013-11-20, terminated 2016-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile. Reason: Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle..
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-20
- Terminated
- 2016-10-13
- Firm location
- Mahwah, NJ, United States
Product description
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
Reason for recall
Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
Data sourced from openFDA. This site is unofficial and independent of the FDA.