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

Recall Z-2550-2014 — Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H TUBE&SCP PLT 135DX8H TUBE&

U.S. FDA — Device Enforcement · United States · 2014-07-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2550-2014
Date of alert
2014-07-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00118109006
Reported risk: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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