Recalls / —
—#138949
Product
Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
- FDA product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K033716
- Affected lot / code info
- Lot Code 3Y0KHP
Why it was recalled
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.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2006
Distribution
- Distribution pattern
- Distributed in WI.
Timeline
- Recall initiated
- 2015-06-25
- Posted by FDA
- 2015-09-23
- Terminated
- 2017-08-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #138949. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.