FDA Device recall Z-0528-2020
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040…
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040… 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-0528-2020 |
| 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
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
Reason
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Identifiers
| code_info | Lots 089610 241030 089600 241020 238180 416260 507280 450740 314580 736790 779690 889140 836030 970200 44…Lots 089610 241030 089600 241020 238180 416260 507280 450740 314580 736790 779690 889140 836030 970200 444550 984630 316530 198990 419500 431591 444655 459030 633280 921380 148200 441530 718410 884690 856150 444530 066610 352090 553250 HA109-05 148190 666010 825420 989490R 989490 444510 444510R 984610 241410 390410 152390 316520 390410R 432706 484710 484720 238170 427280 450730 323210 507270 748450 789870 877610 002130 444500 984600 363080 670430 136700 198960 198970 230290 230300 413443 413444 432705 984600R 148180 441520 456560 732840 825410 889130 970190 444420 984580 921390 530950 120230 198910 198930 230280 413441 803810 803810R 086800 357830 740750 921550 450720 323200 640280 718400 856140 946100 444470 057550 386080 303010 633210 403720 516120 418870 824120 592130 148930 017430 802520 274630 966250 966260 047790 351330 822190 846490 131420 131430 912600 9653 |
|---|
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-0528-2020%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.