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

Recall Z-0424-2015 — Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.

U.S. FDA — Device Enforcement · United States · 2014-10-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0424-2015
Date of alert: 2014-10-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer, Inc.
Product category: device
Product type: Devices

Reported risk: To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.

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.

Recall Z-0424-2015 — Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.

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