FDA Device recall Z-0523-2020
Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-1032…
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-1032… by Zimmer Biomet, citing elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0523-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-21 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111 21-104112 21-104113 21-104114 21-104115 21-104116 21-104117 21-104118 21-104119 21-108110 21-108112 21-108115 21-108117 21-108119 21-108130 21-108132 21-108135 21-108137 21-108139 21-108150 21-108152 21-108155 21-108157 21-108159 21-108251 21-108253 21-108255 21-108257 21-108259 21-108271 21-108273 21-108275 21-108277 21-108279 21-108291 21-108293 21-108295 21-108297 21-108299 21-108391 21-108393 21-108395 21-108397 21-108399 21-109256 21-109260 21-109264 21-109268 21-109272 21-123202 21-123203 21-123204 21-123205 21-123206 21-123207 21-123208 21-123209 21-123210 21-123211 21-123212 21-124309 21-124310 21-124311 21-124312 21-124313 21-124314 21-124315 21-124316 21-124317 US157338 US157340 US157342 US157344 US157346 US157348 US157350 US157352 US157354 US157356 US157358 US157359 US157360 X21-180307 X21-180308 X21-180309 X21-180310 X21-180311 X21-180312 X21-180313 X21-180314 X21-180315 X21-180316 X21-180317 X21-180318 X21-180319 X21-180320 X21-180321 X21-182308 X21-182309 X21-182310 X21-182311 X21-182312 X21-182313 X21-182314 X21-182315 X21-182316 X21-182317 X21-182318 X21-182319 X21-182320 X21-182321 Product Usage: Hip arthroplasty.
Reason
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Identifiers
| code_info | All lots manufactured between January 2008 - May 2019 272750 155610 197670 341720 341750 174760 838240 504840…All lots manufactured between January 2008 - May 2019 272750 155610 197670 341720 341750 174760 838240 504840 360250 735990 174770 272100 742290 414230 133510 723450 642570 642520 504830 020840 115890 679780 642620 679870 344370 642510 790050 360240 708170 707970 707980 788870 788880 642490 360270 742270 669070 642580 642600 642610 569050 888950 548290 823580 788860 888990 360260 708180 790060 642540 133500 708160 766460 642550 790070 669060 707960 888980 012620 824370 969280 943520 974890 974950 969500 589060 788850 504810 504850 969490 973990 969450 995270 504820 708190 969310 969290 969300 974940 956050 838230 642500 974020 974900 974910 974920 974930 969430 974010 613610 974000 568870 591100 341710 458340 956060 670530 056780 956450 723460 969470 969460 974030 360280 679800 874570 685800 797060 200790 679790 622410 642560 960010 056820 073810 790100 074730 969370 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0523-2020%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.