The Recall Desk
ModerateFDA (Devices)·Z-2048-2017·Announced 2017-05-17

Zimmer CAS Recalls NDI P7 Position Sensors for Potential Malfunction

Zimmer CAS is recalling 34 NDI P7 Position Sensors due to a manufacturing issue that may cause them to stop functioning during use.

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, and the source text describes a potential functional failure without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Orthosoft, Inc. dba Zimmer CAS is voluntarily recalling 34 NDI P7 Position Sensors, which are components of the Sesamoid Plasty Camera Arm Kit. These sensors are installed on Sesamoid and Sesamoid Plasty CAS workstations.

The recall is being conducted because a manufacturing issue may cause the affected components to stop functioning during usage. The specific units affected are identified by serial numbers ranging from P7-00321 to P7-00590.

The affected units were distributed worldwide, including to specific US states (KS, MS, WI, NJ, IN, LA, FL, WA) and countries such as Canada, Australia, Singapore, the Netherlands, the UK, Austria, Germany, Switzerland, and the Czech Republic. Users should contact Zimmer CAS for further instructions regarding the replacement or repair of these devices.

The recalled product

Product
NDI P7 Position Sensor, Stereotaxic Instrument
Affected units
34

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 (20)

  • Sesamoid Plasty Camera Arm Kit) Lot/Serial Number: 38 units affected: P7-00321
  • P7-00339
  • P7-00360
  • P7-00361
  • P7-00362
  • P7-00363
  • P7-00364
  • P7-00365
  • P7-00366
  • P7-00368
  • P7-00369
  • P7-00370
  • P7-00371
  • P7-00372
  • P7-00373
  • P7-00375
  • P7-00387
  • P7-00412
  • P7-00414
  • P7-00415

Distribution

Distributed in 8 states: