FDA Device recall Z-1009-2018
fastener, fixation, nondegradable, soft tissue
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of fastener, fixation, nondegradable, soft tissue by Zimmer Biomet, citing it was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1009-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-25 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | AL, CT, FL, IN, NC, NJ, NY, PA, TX, VA, WI |
Product
fastener, fixation, nondegradable, soft tissue
Reason
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
Identifiers
| code_info | Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750…Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370 |
|---|
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-1009-2018%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.