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

Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP… — recall Z-0179-2016

U.S. FDA — Device Enforcement · United States · 2015-09-14 · Class II

As described by U.S. FDA — Device Enforcement: Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral St

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0179-2016
Date of alert
2015-09-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Encore Medical, Lp
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 Distribution
Reported risk: During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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