FDA Device recall Z-1412-2017
Turon Impaction Fixture
- FDA Device
- Class II
- terminated
- Published 2017-03-15
On 2017-03-15 the FDA classified a Class II recall of Turon Impaction Fixture by Encore Medical, citing 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 titani….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1412-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-09 |
| Published | 2017-03-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Encore Medical |
| Distribution | n/a |
Product
Turon Impaction Fixture
Reason
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.
Identifiers
| code_info | 101521L01, 115670L18, 128092L10, 136172L07, 136172L08, 141511L22, 37369L10A, 37369L10B, 37837L23A, 37837L23B, 37837L23C…101521L01, 115670L18, 128092L10, 136172L07, 136172L08, 141511L22, 37369L10A, 37369L10B, 37837L23A, 37837L23B, 37837L23C, 37837L23D, 51103L05E, 51103L05F, 52748L02A, 52748L02B, 52748L02C, 52748L02D, 52748L02E, 52748L02F, 52748L02G, 52748L02H, 57074L05A, 89910L10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1412-2017%22
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