Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1600-2015·Announced 2015-05-20

Synthes Recalls TFNA Proximal Femoral Nails Due to Locking Mechanism Defect

Synthes, Inc. is recalling 8,175 TFNA Proximal Femoral Nails because the locking mechanism was assembled too close to the top, potentially causing surgical delays.

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 stated impact is a surgical delay rather than a direct physical injury or permanent harm, fitting the criteria for a moderate severity recall.

Plain-English summary

Synthes, Inc. is recalling 8,175 units of the TFN-ADVANCED Proximal Femoral Nailing System (TFNA). The recall involves specific lots of nails that were assembled with a locking mechanism positioned too close to the top of the nail. The product is used for the treatment of fractures in orthopedics and trauma.

The defect in the locking mechanism may result in a surgical delay for patients. The recall covers distribution in the United States and Switzerland. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities should check their inventory for the affected part numbers and lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to Synthes, Inc. according to the company's instructions.

The recalled product

Product: TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
Manufacturer: Synthes, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: mechanical-defect
surgical-delay
Affected units: 8,175

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 (20)

7719463
7720282
7720284
7720286
7733222
7736898
7753327
7758716
7758854
7762047
7764202
7769340
7791304
7802737
7804159
7806085
7812037
7812039
7819851
7820508

Distribution

Distributed nationwide across the United States.

Same manufacturer · Synthes, Inc.

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Same hazard · mechanical defect