Data Foundry

Medical device recalls 2016

Streamline OCT Occipito-Cervico-Thoracic System — Class II medical device recall Z-1829-2016

Terminated recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), reported 2016-06-01, distributed nationwide. Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver fr

Recall numberZ-1829-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Marquette, MI, United States
Recall initiated2016-04-22
Classified2016-05-26
Reported by FDA2016-06-01
Terminated2017-02-08
DistributedNationwide (US)
Quantity17 devices
Lot numbers170684
Model numbers26-COUNTER-T-XLINK

Product

Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.

Reason for recall

Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.

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-1829-2016. 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.