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

Recall Z-1101-2016 — Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400 12/14 UNIPOLAR FEMORA

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-1101-2016
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): 62097104

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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