The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1380-2021·Announced 2021-04-21

Arthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error

Arthrex, Inc. is recalling 32 units of Tibial Opening Wedge Osteotomy Plates because five parts were incorrectly processed as a different model.

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 or injuries, indicating a theoretical risk of harm rather than a confirmed adverse event.

Plain-English summary

Arthrex, Inc. is recalling 32 units of the Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm (Part number: AR-13200T-15.0; Lot code: 12135408). The recall was initiated after it was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

The affected devices are used in the treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur. The recall covers units distributed worldwide, including nationwide distribution in the United States in the states of GA, LA, CA, FL, OR, and TX, as well as in India, Russia, the Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.

Healthcare providers and patients should contact Arthrex, Inc. for instructions on how to return the affected devices. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Manufacturer
Arthrex, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
32

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)

  • Part number: AR-13200T-15.0
  • Lot code:12135408

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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