FDA Device recall Z-1383-2017
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery by Synthes Usa Products, citing these items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820.350 lot 5919005 is a 12 mm Strut. The item etched and labeled as 12 mm Strut 03.82….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1383-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-31 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | LA, TX |
Product
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy
Reason
These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820.350 lot 5919005 is a 12 mm Strut. The item etched and labeled as 12 mm Strut 03.820.352 lot 5919006 is a 10 mm Strut.
Identifiers
| code_info | Part numbers 03.820.350 Lot 5919005 and 03.820.352, lot 5919006 |
|---|
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-1383-2017%22
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