Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
This recall has been terminated (originally issued September 23, 2015).
- Recall Initiated
- June 25, 2015
- Posted
- September 23, 2015
- Terminated
- August 30, 2017
- Recall Number
- Z-2810-2015
- Quantity
- 16 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.
Distribution
Distributed in WI.
Lot / Code Info
Lot Code 3Y0KHP
Root Cause
Nonconforming Material/Component
Action Taken
Stryker Orthopaedics notified their branches via email on 6/25/2015. Notification letters and Product Accountability Forms were mailed to Stryker Branches/Agencies on 817/2015 and hospital risk management on 8/18/2015.
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