The Recall Desk
ModerateFDA (Devices)·Z-1352-2015·Announced 2015-04-08

Synthes Aiming Arms Recalled Due to Potential Jamming of Guide Sleeve

Synthes, Inc. is recalling 131 Aiming Arms from the TFN-ADVANCED system because the guide sleeve may jam, potentially delaying instrument removal.

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. The hazard involves a mechanical jam that may delay instrument removal, which is a procedural inconvenience rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity score.

Plain-English summary

Synthes, Inc. is recalling 131 units of the 130 Degree Aiming Arm and 125 Degree Aiming Arm. These components are part of the TFN-ADVANCED (TFNA) Proximal Femoral Nailing System, which is intended for the treatment of fractures in adults and adolescents (ages 12-21) whose growth plates have fused.

The recall was initiated because the guide sleeve has the potential to jam within the Aiming Arms. This mechanical issue may delay the disassembly and removal of the instruments during or after a procedure.

The affected units were distributed nationwide in the United States, specifically in New York, Texas, Maryland, Oregon, Mississippi, North Dakota, California, Arizona, Michigan, Illinois, Pennsylvania, Tennessee, Arkansas, South Dakota, South Carolina, Florida, Virginia, Oklahoma, and Georgia. Healthcare facilities should stop using the affected devices and contact Synthes, Inc. for further instructions.

The recalled product

Product
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in
Manufacturer
Synthes, Inc.
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
131

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 (15)

  • Part Numbers: 03.037.013
  • 03.037.014
  • Lot Numbers: 8903848
  • 9124017
  • 903851
  • 9124019
  • 8918566
  • 9124022
  • 9124012
  • 9124023
  • 9124014
  • 9124026
  • 9124016
  • 9124027
  • 8918563

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Related recalls

Same manufacturer · Synthes, Inc.

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