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

Recall Z-1738-2015 — R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk

U.S. FDA — Device Enforcement · United States · 2015-05-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1738-2015
Date of alert: 2015-05-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smith & Nephew, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 71339160

Reported risk: The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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