PlainRecalls
FDA Devices Moderate Class II Terminated

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 th

Reported: November 28, 2012 Initiated: September 20, 2012 #Z-0416-2013

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.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
24 USA; 71 worldwide
Distribution
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
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Zimmer, Inc.. Units affected: 24 USA; 71 worldwide.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2012. Severity: Moderate. Recall number: Z-0416-2013.

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