CLASS II Device recall · Reported 11 Nov 2020 · FDA Enforcement Report
Streamline MIS Navigation System Taps recalled by RTI Surgical, Inc. (
RTI Surgical, Inc. ( is recalling Streamline MIS Navigation System Taps, distributed in Michigan. The recall was initiated on 11 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0320-2021
- FDA event ID
- 86591
- Recalling firm
- RTI Surgical, Inc. (, Marquette, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Sep 2020
- FDA classified
- 31 Oct 2020
- Reported
- 11 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Sep 2020 | Recall initiated by company | |
| 31 Oct 2020 | Classified by FDA | +50 days |
| 11 Nov 2020 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
Product as listed by the FDA
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
Where it was distributed
Product distributed to Surgalign, a distributor located in Michigan.
Questions about this recall
Is Streamline MIS Navigation System Taps recalled?
Yes. RTI Surgical, Inc. ( recalled Streamline MIS Navigation System Taps on 11 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0320-2021.
Why was it recalled?
The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
Which lots are affected?
Lot numbers 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733
Where was it sold?
Product distributed to Surgalign, a distributor located in Michigan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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