The Recall Desk
HighFDA (Devices)·Z-0977-2026·Announced 2025-12-31

Neurostimulator programmer app recalled over a device reset message that persisted

Medtronic Neuromodulation is recalling 7,667 Restore Clinician Programmer Application devices after a Device Reset message could not be cleared, in rare cases preventing therapy from resuming.

What this means for you

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: Scored 3 under the risk-of-harm criterion: the firm states the fault has in rare cases prevented therapy resuming and required surgical replacement of the implant.

Plain-English summary

The Restore Clinician Programmer Application (CP App), model A71100, used with the CT900A, CT900B, CT900C and CT900D clinician tablet programmers, is being recalled by Medtronic Neuromodulation.

The record cites a software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. The firm states that resolution would require surgical replacement of the implanted neurostimulator.

The record lists 7,667 devices. The CP App carries UDI-DI 00763000273668, and all software versions prior to v.1.0.4489 are affected. Distribution was worldwide, including nationwide in the United States and to a wide range of other countries. The FDA has classified the action as Class II.

Patients should not act on this notice alone and should contact the clinic that manages their device; clinicians should follow Medtronic's instructions.

The recalled product

Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A
Manufacturer
Zimmer, Inc.
Category
Medical Device — Neurostimulator programmer
Hazard
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Lot Code: Model No 815609360
  • UDI-DI (01)00887868144493(17)340820(10)66717603
  • Lot Number 66717603 Model No 815609360
  • UDI-DI (01)00887868144493(17)340905(10)66892902
  • Lot Number 66892902 Model No 815609360
  • UDI-DI (01)00887868144493(17)341030(10)67031550
  • Lot Number 67031550

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 17 recalled by Zimmer, 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 17 products in this recall →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · software fault

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