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.
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. 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)…
- Manufacturer
- Synthes, Inc.
- 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
Related recalls
Same manufacturer · Synthes, Inc.
See all →- ModerateSynthes Recalls MatrixNEURO Screws Due to Incorrect Body Clip Labeling
FDA (Devices) · 2020-08-05
- ModerateSynthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect
FDA (Devices) · 2020-02-05
- ModerateSynthes 2.4mm Sterile Locking Screw Recall Due to Packaging Defect
FDA (Devices) · 2020-02-05
- ModerateSynthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect
FDA (Devices) · 2020-02-05
- ModerateSynthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect
FDA (Devices) · 2020-02-05
Similar recalls
- HighSynthes Recalls Five TFN-Advanced Proximal Femoral Nailing Systems
FDA (Devices) · 2015-12-16
- ModerateSynthes Recalls TFNA Proximal Femoral Nails Due to Locking Mechanism Defect
FDA (Devices) · 2015-05-20
- HighSynthes TFN-Advanced Femoral Nail Recalled for Dimensional Labeling Mismatch
FDA (Devices) · 2023-03-22
- HighSynthes Thumb Screws Recalled Due to Incorrect Stainless Steel Material
FDA (Devices) · 2015-03-25
- HighTFN-Advanced Femoral Nails May Have Incorrect Length Markings
FDA (Devices) · 2023-03-22
- SevereSynthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend
FDA (Devices) · 2013-12-11