Device product
Trinity Acetabular Shell Product Usage: Total Hip Replacement.
Z-1527-2016
Product summary
- Event
- Event 73205
- Status
- Terminated
- Classification
- Class II
- Quantity
- 629 devices in total
- Official record key
device-enforcement:Z-1527-2016
Official wording
Reason: Potential for abrasion of the sterile barrier pouches of the new packaging system.
Code information: Cluster Shell 044mm Taper Size 1, Lot Code: 320023; Cluster Shell 046mm Pager Size 2, Lot Code: 320018; Cluster Shell 048mm Taper Size 2, Lot Codes: 321691, 322402, 322981, 322982, 323745, 323746, 324298; Cluster Shell 050mm Taper Size 2, Lot Codes: 321954, 322753, 322980; Cluster Shell 050mm Taper Size 3, Lot Codes:
Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa and UK.
Derived failure modes
-
Unknown
Potential for abrasion of the sterile barrier pouches of the new packaging system.