The Recall Desk
HighFDA (Devices)·Z-2618-2026·Announced 2026-07-08

Medacta Short Monobloc Stem Broaches Surgical Instruments Shoulder Implant

Medacta USA is recalling Short Monobloc Stem Broaches used in shoulder replacement surgery due to positioning misalignment that may increase risk of fracture in the upper arm bone.

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 an FDA Class II recall of a surgical instrument used in high-risk orthopedic procedures where the identified defect (positioning misalignment) creates a risk of serious harm (fracture). No injuries or deaths are reported in the source, but the potential for fracture in a surgical implant context meets the High threshold for risk-of-harm products.

Plain-English summary

Medacta USA Inc is recalling Short Monobloc Stem Broaches, sizes 7–16 (REF 04.01.10.0970–04.01.10.0979), part of the Medacta Shoulder System. These surgical instruments are used during shoulder arthroplasty (replacement) procedures.

The recalled broaches do not properly replicate the intended implant geometry during use. Specifically, the reaming guide and stem reamer are positioned approximately 0.2 mm per size more laterally than intended. This misalignment may increase the risk of fracture in the medial region of the proximal humerus (upper arm bone).

A total of 50 units were distributed nationwide in Colorado, Arkansas, Indiana, Pennsylvania, Utah, and Florida. Affected lot numbers and UDI codes are listed in the product identification data.

Patients or healthcare providers who have received this device should contact Medacta USA Inc or consult with their surgical team regarding appropriate follow-up care.

The recalled product

Product
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
Manufacturer
Medacta Usa Inc
Category
Medical Device — Surgical Instruments / Orthopedic
Hazard
  • fracture-risk
  • positioning-defect

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 (10)

  • REF/UDI/Lot: 04.01.10.0970/07630542768910/2585086
  • 04.01.10.0971/07630542768927/2585087
  • 04.01.10.0972/07630542768934/2585088
  • 04.01.10.0973/07630542768941/2585089
  • 04.01.10.0974/07630542768958/2585090
  • 04.01.10.0975/07630542768965/2585091
  • 04.01.10.0976/07630542768972/2585092
  • 04.01.10.0977/07630542768989/2585093
  • 04.01.10.0978/07630542768996/2585094
  • 04.01.10.0979/07630542769009/2585095

Distribution

Distributed nationwide across the United States.

Related recalls

Same category