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

Recall Z-2310-2012 — OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZEDMatch Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial ComponentsREF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. The Optetrak Logic Total Knee System

U.S. FDA — Device Enforcement · United States · 2011-08-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2310-2012
Date of alert: 2011-08-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Exactech, Inc.
Product category: device
Product type: Devices

Reported risk: Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.

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.

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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