Device product
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
Z-0386-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 63126
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0386-2013
Official wording
Reason: Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.
Code information: Item 00-6334-062-36, Lot 62023769
Distribution pattern: USA (nationwide) including the states of Ohio, Carolinas and New England.
Derived failure modes
-
Unknown
Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.