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

Recall Z-1117-2016 — Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145 NOCOAT 763301300 C

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-1117-2016
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): 62222763

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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