The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0299-2021·Announced 2020-11-04

RTI Surgical Recalls Streamline MIS Navigation System Taps Due to Binding

RTI Surgical is recalling 420 units of Streamline MIS Navigation System Taps because they have experienced binding with other devices.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (binding) that poses a risk of harm during surgery, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling 420 units of Streamline MIS Navigation System Taps. The affected products include various catalog numbers such as 04-CANNDRILL-MDN, 04-CANNTAP-40-MDN, and 05-SIMPDRIVER-MDN. These devices are intended to be used during spinal surgery to assist surgeons in precisely locating anatomical structures.

The recall was initiated because the Streamline Navigation System taps have experienced binding with other devices. The affected lots are 377520, 371734, 374791, 374792, 373438, 371735, 371736, 377625, 377806, 371737, 372819, 371266, and 371733.

The products were distributed nationwide in the United States, including in the state of Michigan. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
Streamline MIS Navigation System Taps, Catalog Nos. 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 Product Usage…
Manufacturer
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Category
Medical Device — Surgical Instruments
Hazard
Affected units
420

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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