Device recall: Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN…

Class II FDA enforcement event 86591. Recall start date: 11 Sep 2020. Status in the FDA record: Terminated. Termination date: 23 May 2024.

Reason for recall, in the words of FDA

The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) started this device recall on 11 Sep 2020. The firm address in the FDA record is in Marquette, MI. FDA put the recall in Class II. FDA event 86591 has 1 product record. The first FDA enforcement report date is 11 Nov 2020. The record gives the status Terminated, with the termination date 23 May 2024.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Product distributed to Surgalign, a distributor located in Michigan.

Recalling firm

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Marquette, MI.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 86591: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0320-2021	Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN	143 units	Class II	Terminated	11 Nov 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Initiated	Product (first record)	Type	Class	Records
15 Jan 2021	CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for	Device	Class II	41
24 Sep 2020	Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-M	Device	Class II	2
24 Sep 2020	Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-	Device	Class II	1
16 Sep 2016	RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intend	Device	Class II	1
22 Apr 2016	Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.	Device	Class II	1
18 Mar 2016	RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver	Device	Class II	1
29 May 2015	Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be util	Device	Class II	1
21 May 2015	Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEE	Device	Class II	1

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.): all 9 events

Official channels

FDA enforcement report Z-0320-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 86591. https://recallregister.com/fda/ii/86591/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Product distributed to Surgalign, a distributor located in Michigan.
What quantity of product is in FDA event 86591?: The FDA record gives this quantity: 143 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.