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Open, Classified

Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.

FDA Recall Z-0322-2021 · Posted 2020-11-02

Recalling FirmRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Recall StatusOpen, Classified
Product CodeOLO
Date Initiated2020-09-24
Product Quantity76 units

Reason for Recall

System does not include a drill guide.

Firm Action

On September 24, 2020, the firm sent an Urgent Medical Devices Recall letter to customers to inform them of the product issue. Customers were instructed to remove affected product from all user sites and inventory locations. Customers are to return these instrument systems to RTI Surgical using RGA number 63000897 along with a completed copy of the Acknowledgement and Receipt Form. If the product has been further distributed, please immediately notify your customers by providing them a copy of the recall letter and the response form for completion.

Root Cause

Device Design

Distribution Pattern

Distributed to one distributor in Michigan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2020-06-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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