Z-0416-2013 Class II Terminated
FDA device recall Z-0416-2013 was initiated by Zimmer, Inc. on Sep 20, 2012 and is designated Class II. Reason for recall: Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported. The recall status is terminated (terminated Apr 18, 2014). Affected quantity: 24 USA; 71 worldwide.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2012
- Initiation Date
- Sep 20, 2012
- Termination Date
- Apr 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 USA; 71 worldwide
Product Description
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused Hip, fracture of the pelvis, and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.
Reason for Recall
Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported.
Distribution Pattern
Worldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK
Code Information
REF 6200-056-22, lot 62010615
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0416-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026