The Recall Desk
HighFDA (Devices)·Z-0372-2023·Announced 2022-12-14

Shoulder Surgical Navigation System Warning for Bone Stability

A warning has been added to the NextAR Shoulder surgical navigation platform advising verification of adequate coracoid bone stability. Inadequate stability could lead to bone fracture during reverse shoulder surgery.

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: This is a risk-of-harm surgical device where bone fracture during the procedure could result in serious injury. No injuries have been reported. The recall is classified as FDA Class II and involves adding a prospective safety warning to prevent potential adverse events.

Plain-English summary

The FDA is advising users of the NextAR Shoulder surgical technique and navigation platform to verify adequate coracoid bone stability prior to proceeding with the reverse shoulder arthroplasty procedure.

According to the warning, osteoporosis, weakness of the coracoid process, or other deficiencies in bone stability could lead to adverse events including bone fracture. The manufacturer has added a requirement to verify that the patient's coracoid bone and relevant patient conditions are suitable before placement of the NextAR Shoulder Target Holder.

This recall affects 14 units of the NextAR RSA Platform distributed in Alabama, Florida, New Hampshire, Colorado, Illinois, South Carolina, and Arkansas. The notification applies to Document Reference Code 99.81NEXTAR.12US (Revision 02 and previous versions).

The recalled product

Product
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
Manufacturer
Medacta Usa Inc
Category
Medical Device — Surgical Navigation / Orthopedic
Hazard
Affected units
14

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 (2)

  • Document Reference Code 99.81NEXTAR.12US (for US market only)
  • Revision Numbers: Rev.02 and previous

Distribution

Distributed in 7 states:

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