Z-1413-2017 Class II Terminated
FDA device recall Z-1413-2017 was initiated by Encore Medical, Lp on Feb 9, 2017 and is designated Class II. 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… The recall status is terminated (terminated Oct 20, 2017). Affected quantity: 626 units.
Recall details
- Product Type
- Devices
- Report Date
- Mar 15, 2017
- Initiation Date
- Feb 9, 2017
- Termination Date
- Oct 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 626 units
Product description
RSP 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.
Distribution pattern
US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
Code information
109931L01, 109931L02, 115670L15, 115670L16, 128092L08, 128092L09, 137917L16, 167829L06, 52258L01, 52258L01A, 67428L01, 76386L01, 76386L02, 81722L01, 81722L02
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1413-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026