Zimmer Biomet Recalls Phoenix Antegrade Femoral Nail Connecting Bolts
Zimmer Biomet is recalling 337 Phoenix Antegrade Femoral Nail Connecting Bolts because the bolt may fracture during insertion of the femoral nail.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device that could cause the instrument to fracture during a surgical procedure. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 337 units of the Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. This orthopedic instrument is distributed nationwide in the United States.
The recall is due to a risk of the bolt fracturing while connecting the insertion guide to the intramedullary nail during the insertion of the femoral nail. The affected units are identified by specific finished lot order codes, including M370490, M354450, and M321540, among others.
Healthcare providers and facilities should stop using the affected connecting bolts and contact Zimmer Biomet for further instructions on the recall.
The recalled product
- Product
- Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. 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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