The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1023-2017·Announced 2017-01-25

Medacta M.U.S.T. Rods Recalled for Damaged Packaging and Sterility Issues

Medacta USA Inc. is recalling 82 M.U.S.T. Rods due to damaged packaging and lack of sterility assurance. The recall covers units distributed in the US and several international countries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Medacta USA Inc. is recalling 82 units of M.U.S.T. Rods, reference 03.50.433, size 5.5mm, length 480mm, straight type, made of Co-Cr-Mo material. These rods are medical devices used as connectors between pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. The specific lots involved are 125212, 144216, and 148146.

The recall was initiated due to damaged packaging and a lack of sterility assurance. The affected units were distributed worldwide, including nationwide distribution in the United States to the states of Texas and Colorado, as well as to Australia, Belgium, Spain, Germany, Italy, and Switzerland.

Healthcare providers and patients who have these specific rods implanted or in inventory should contact Medacta USA Inc. for further instructions. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine.…
Manufacturer
Medacta Usa Inc
Category
Medical Device — Orthopedic Spinal Fixation
Hazard
Affected units
82

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 (3)

  • Lot #s 125212
  • 144216
  • 148146

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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