Turon Impaction Fixture
Reported: March 15, 2017 Initiated: February 9, 2017 #Z-1412-2017
Product Description
Turon Impaction Fixture
Reason for Recall
During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 297 units
- Distribution
- US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
Turon Impaction Fixture. Recalled by Encore Medical, Lp. Units affected: 297 units.
Why was this product recalled? ▼
During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2017. Severity: Moderate. Recall number: Z-1412-2017.
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