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

Recall Z-0067-2018 — Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone w

U.S. FDA — Device Enforcement · United States · 2017-06-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0067-2018
Date of alert: 2017-06-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Encore Medical, Lp
Product category: device
Product type: Devices

Reported risk: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.

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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