Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The… — Class II medical device recall Z-0180-2016
Terminated recall by Encore Medical, Lp, reported 2015-11-04, distributed nationwide. During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixtur
| Recall number | Z-0180-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2015-09-14 |
| Classified | 2015-10-28 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2016-11-04 |
| Distributed | Nationwide (US) |
| Quantity | 634 units |
| Lot numbers | 52748L02A |
| Model numbers | 804-03-053 |
Product
Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems.
Reason for recall
During the 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-0180-2016. 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.