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

Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14… — recall Z-2127-2016

U.S. FDA — Device Enforcement · United States · 2016-05-26 · Class II

As described by U.S. FDA — Device Enforcement: Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumati

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2127-2016
Date of alert
2016-05-26
Country / jurisdiction
United States
Risk level
Class II
Notice type
recall
Brand
Exactech, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribuiton to OK, ME, NY, & Hawaii.
Reported risk: Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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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.