RSP Impaction Fixture — Class II medical device recall Z-1413-2017
Terminated recall by Encore Medical, Lp, reported 2017-03-15. During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction
| Recall number | Z-1413-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2017-02-09 |
| Classified | 2017-03-08 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2017-10-20 |
| Countries outside the US | AU, CA, DE, GB, IE, KR |
| Quantity | 626 units |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1413-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.