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.
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, 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.
- 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.
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