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U.S. Department of Health and Human Services

Class 2 Device Recall Streamline OCT Navigated Instruments

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 Class 2 Device Recall Streamline OCT Navigated Instrumentssee related information
Date Initiated by FirmSeptember 24, 2020
Date PostedNovember 02, 2020
Recall Status1 Open3, Classified
Recall NumberZ-0322-2021
Recall Event ID 86595
510(K)NumberK200095 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductStreamline 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.
Code Information Lots  370855 373847 373848 373849 377629 373850 373846 
FEI Number 1000115331
Recalling Firm/
Manufacturer		 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
375 River Park Cir
Marquette MI 49855-1781
For Additional Information ContactChristine Thomas
906-226-9909
Manufacturer Reason
for Recall		System does not include a drill guide.
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce76 units
DistributionDistributed to one distributor in Michigan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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