The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0300-2021·Announced 2020-11-04

RTI Surgical Recalls Streamline TL Navigation System Taps Due to Binding

RTI Surgical is recalling 420 units of Streamline TL 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.

Plain-English summary

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling 420 units of the Streamline TL Navigation System. The affected products include various catalog numbers for taps and inserters intended for use during spinal surgery to assist surgeons in locating anatomical structures.

The recall was initiated because the Streamline Navigation System taps have experienced binding with other devices. The affected lots were distributed nationwide in the United States, including in the state of Michigan.

Healthcare facilities and consumers should stop using the affected products and contact the recalling firm for further instructions or a replacement.

The recalled product

Product
Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MDN 02-RS-INSERTER-MDN 02-SCREWINS-CL-MDN 02-SCREWINS-C-MDN…
Manufacturer
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Category
Medical Device — Surgical Instrument
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

Same manufacturer · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

See all →

Same hazard · mechanical failure

See all →

Similar recalls