Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0875-2015 — 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 (N

U.S. FDA — Device Enforcement · United States · 2014-12-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0875-2015
Date of alert
2014-12-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Manufacturing B.V.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
62714305
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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