Comprehensive Reverse Shoulder System Humeral Tray Model 115340 — Class I medical device recall Z-1103-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-02-22, distributed nationwide. Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
| Recall number | Z-1103-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-12-20 |
| Classified | 2017-02-10 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2017-08-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, CO, KR, NL |
| Quantity | 4,388 |
| Lot numbers | 016140, 026690, 041870, 041880, 041890, 049710, 049740, 052860, 060500, 070330, 075330, 085130, 118250, 118260, 118270, 118280, 118290, 118300, 118340, 118350, 118360, 118370, 118380, 118390, 132020, 132030, 153330, 153340, 153350, 153360, 153370, 153380, 153390, 153400, 153410, 153420, 153430, 159650, 159660, 161960 and 362 more |
| Model numbers | 115340 |
Product
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Reason for recall
Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
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-1103-2017. 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.