PRODISC Orthopedic Manual Surgical Instrument — Class II medical device recall Z-1383-2017
Terminated recall by Synthes (USA) Products LLC, reported 2017-03-08, distributed in LA, TX. These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820.350 lot 59190
| Recall number | Z-1383-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2017-01-31 |
| Classified | 2017-02-28 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2017-12-01 |
| Distributed | LA, TX |
| Quantity | 2 units |
| Reason classes | labeling |
| Lot numbers | 03.820.352, 5919005, 5919006 |
| Model numbers | 03.820.350, 03.820.352 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1383-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.