Z-1412-2017 Class II Terminated
FDA device recall Z-1412-2017 was initiated by Encore Medical, Lp on February 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 coati… The recall status is terminated (terminated October 20, 2017). Affected quantity: 297 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2017
- Initiation Date
- February 9, 2017
- Termination Date
- October 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 297 units
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.
Distribution Pattern
US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
Code Information
101521L01, 115670L18, 128092L10, 136172L07, 136172L08, 141511L22, 37369L10A, 37369L10B, 37837L23A, 37837L23B, 37837L23C, 37837L23D, 51103L05E, 51103L05F, 52748L02A, 52748L02B, 52748L02C, 52748L02D, 52748L02E, 52748L02F, 52748L02G, 52748L02H, 57074L05A, 89910L10