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.
- Recall Initiated
- September 24, 2020
- Posted
- November 2, 2020
- Recall Number
- Z-0322-2021
- Quantity
- 76 units
- Firm Location
- Marquette, MI
Reason for Recall
System does not include a drill guide.
Distribution
Distributed to one distributor in Michigan.
Lot / Code Info
Lots 370855 373847 373848 373849 377629 373850 373846
Root Cause
Device Design
Action Taken
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.
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