The Recall Desk
ModerateFDA (Devices)·Z-0320-2021·Announced 2020-11-11

RTI Surgical Recalls Streamline MIS Navigation System Taps

RTI Surgical is recalling 143 units of Streamline MIS Navigation System Taps because they are not compatible with the Streamline MIS tap sleeve.

What this means for you

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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a functional incompatibility rather than a high-risk pathogen or structural defect causing harm.

Plain-English summary

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling 143 units of Streamline MIS Navigation System Taps. The recall involves specific catalog numbers including 04-CANNDRILL-MDN, 04-CANNTAP-40-MDN, and others, across 13 distinct lot numbers.

The reason for the recall is that the Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve. This incompatibility is a functional defect rather than a reported injury or contamination issue.

The product was distributed to Surgalign, a distributor located in Michigan. No illnesses, injuries, or deaths have been reported in connection with this recall.

The recalled product

Product
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
Manufacturer
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Category
Medical Device — Surgical Instruments
Hazard
Affected units
143

Distribution

Distributed in 1 state:

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