FDA Device recall Z-1173-2018
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Recons…
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Recons… by Biomet, citing during assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the scre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1173-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-28 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet |
| Distribution | US |
Product
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
Reason
During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.
Identifiers
| code_info | Model numbers: 211250 211251 211252 211253 211254 211255 Lot codes: 095580 119120 130020 142530 155910 1…Model numbers: 211250 211251 211252 211253 211254 211255 Lot codes: 095580 119120 130020 142530 155910 162450 162460 241160 257860 304290 305860 309730 337610 389790 400730 419380 430570 443670 545430 546260 548290 550390 586120 606830 611540 636370 636470 688540 704020 714760 793670 806070 829520 829530 881230 950270 970920 019600 110780 130040 157180 185620 203520 241180 278580 330870 364380 424550 430580 457210 544340 583360 636520 706690 714810 810260 853250 881330 883830 891880 923660 923680 991400 033700 053800 062210 110790 160770 185630 241190 247810 257870 347080 583370 611530 636680 638640 674650 688550 775020 829540 848530 889330 950310 976390 988380 991410 028450 028460 053810 062220 098020 155900 160780 231490 241230 251120 251920 257880 281140 330880 347100 367850 400390 450780 493220 494170 527200 546290 548460 548470 548580 586130 611520 636710 66 |
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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-1173-2018%22
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