FDA Device recall Z-2304-2020
Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and st…
- FDA Device
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and st… by Biomet, citing distributed to the field without having completed design history files or design transfer activities.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2304-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-14 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet |
| Distribution | US |
Product
Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Reason
Distributed to the field without having completed design history files or design transfer activities
Identifiers
| code_info | Lot Number: 624830 (01)00887868133749(17)260414(10)624830 867210 (01)00887868133749(17)260730(10)867210 |
|---|
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-2304-2020%22
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