Zimmer Recalls ZNN Antegrade Femoral Nail Due to Potential Denting
Zimmer, Inc. is recalling eight ZNN Antegrade Femoral Nail units because a single distributed unit may have been dented, posing a risk of implant fatigue.
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. According to the rubric, FDA Class II recalls with reports of hospitalization or significant injury/property damage are rated as Severe (4). The source describes a risk of implant failure requiring revision surgery, which aligns with significant injury criteria.
Plain-English summary
Zimmer, Inc. is recalling eight units of the ZNN Antegrade Femoral Nail (ZNN AF), an orthopedic internal fixation device. The recall is due to a potential defect where a single distributed unit may have been dented. This denting creates a potential for fatigue of the implant before the fracture has sufficiently healed.
The affected units are identified by Part 47-2492-320-10 and lot 62763724. The distribution pattern includes worldwide distribution, specifically in the US states of North Carolina and Alaska, as well as Taiwan, Japan, and Germany. If the implant fatigues, it may result in the need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.
Patients who have received this specific device should contact their healthcare provider to discuss the recall and determine if any further action is necessary.
The recalled product
- Product
- ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 8
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 (2)
- Part 47-2492-320-10
- lot 62763724
Distribution
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