Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 3
FDA device recall Z-0964-2014 · posted 2014-02-10 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
- Action taken
- Stryker Orthopaedics sent notification letters and acknowledgement forms via Fed Ex as follows: Branches-11/20/2013 Hospital Risk Manager - 11/21/2013
- Root cause
- Process design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 211 units
- Distribution
- IL MA, MN, ND, OR, & PA
- Date initiated
- 2013-11-20
- Date posted
- 2014-02-10
- Date terminated
- 2016-10-13
- Location
- Mahwah, NJ
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