FDA Device recall Z-1103-2017
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
- FDA Device
- Class I
- terminated
- Published 2017-02-22
On 2017-02-22 the FDA classified a Class I recall of Comprehensive Reverse Shoulder System Humeral Tray Model 115340 by Zimmer Biomet, citing higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1103-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-12-20 |
| Published | 2017-02-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Reason
Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
Identifiers
| code_info | Lot numbers 016140 026690 041870 041880 041890 049710 049740 052860 060500 070330 075330 085130 118250 11…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 172670 208280 208290 212200 212230 212240 215990 216000 216010 228630 228640 228650 228660 228670 256990 257000 257010 257020 278300 278310 278320 278330 278550 278560 278580 278590 300090 300100 300110 300120 300130 300140 300150 307790 310580 310590 310600 310610 310620 320150 329390 334260 334370 349140 349150 351030 351040 359610 359630 359640 359650 359660 359680 361860 361870 361880 361890 361900 367300 367310 367320 367330 367340 367350 367360 367370 367380 372290 372310 372320 384350 385090 391660 402880 411980 413530 415040 415050 415060 415070 415080 415090 420630 424 |
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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-1103-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.