Zimmer Biomet Recalls Antegrade Femoral Nail Instrument Kits
Zimmer Biomet is recalling 337 Antegrade Femoral Nail Instrument Kits because a bolt may fracture during use, potentially affecting patients undergoing orthopedic surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device used during surgery, which poses a significant risk of injury or procedural failure.
Plain-English summary
Zimmer Biomet, Inc. is recalling 337 units of the 14-442000S Antegrade Femoral Nail Instrument Kit. The recall is due to a defect where the bolt connecting the insertion guide to the intramedullary nail may fracture during the insertion of the femoral nail.
The affected products were distributed nationwide in the United States. The recall covers specific finished lot orders, including M370490, M354450, and M321540, among others.
Healthcare providers and patients should stop using the affected instrument kits and contact Zimmer Biomet for instructions on returning the products or obtaining replacements.
The recalled product
- Product
- 14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 337
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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