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U.S. Department of Health and Human Services

Class 2 Device Recall Trilogy Cups

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  Class 2 Device Recall Trilogy Cups see related information
Date Initiated by Firm December 04, 2014
Date Posted December 24, 2014
Recall Status1 Terminated 3 on June 18, 2015
Recall Number Z-0875-2015
Recall Event ID 69814
510(K)Number K934765  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD

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.
Code Information Item No. 00-6200-054-20; Lot 62714305
Recalling Firm/
Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
Manufacturer Reason
for Recall
Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated and affects only lot 62714305, which
FDA Determined
Cause 2
Under Investigation by firm
Action The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" memo dated 12/4/2014 to its customers. The memo described the product, problem and actions to be taken. The customers were instructed to locate all product from the listed lot and quarantine them immediately; carry out a physical count of all affected product in inventory; complete and return the Inventory Return Certification Form via email to: corporatequality.postmarket@zimmer.com on or before 12/12/2014; return the recalled product along with Inventory Return Certification Form on or before 12/12/2014; keep and maintain a copy for your records; and notify Zimmer of any hospitals that you have further distributed the affected product to and complete spreadsheet template provided. After reviewing this notification you have further questions or concerns, call the customer call center at 1-800-348-2759 between 8:00 am and 5:00 pm EST.
Quantity in Commerce 68 units
Distribution Worldwide Distribution: US (nationwide) and countries of: France, Germany, Iran, Romania, Serbia, Singapore, Taiwan, and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = ZIMMER, INC.