Z-0386-2013 Class II Terminated
FDA device recall Z-0386-2013 was initiated by Zimmer, Inc. on Aug 27, 2012 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Aug 27, 2013). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2012
- Initiation Date
- Aug 27, 2012
- Termination Date
- Aug 27, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
Reason for Recall
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.
Distribution Pattern
USA (nationwide) including the states of Ohio, Carolinas and New England.
Code Information
Item 00-6334-062-36, Lot 62023769
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0386-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026