Recall Z-0416-2013— Zimmer, Inc.

Class II FDA medical device recall by Zimmer, Inc., initiated 2012-09-20, terminated 2014-04-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..

Recalling firm

Zimmer, Inc.

Classification

Class II

Status

Terminated

Initiated

2012-09-20

Terminated

2014-04-18

Firm location

Warsaw, IN, United States

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