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

Recall Z-1161-2016 — Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O 620004820 TRILOGY ACET SHELL

U.S. FDA — Device Enforcement · United States · 2016-01-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1161-2016
Date of alert: 2016-01-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Manufacturing B.V.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 61564135

Reported risk: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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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