FDA Device recall Z-0349-2020
MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T…
- FDA Device
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T… by Synthes Usa Products, citing modified outside of approved manufacturing process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0349-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-05 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Synthes Usa Products |
| Distribution | AR |
Product
MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle
Reason
Modified outside of approved manufacturing process
Identifiers
| code_info | Unknown |
|---|
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-0349-2020%22
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