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.
What this means for you
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · structural failure
See all →- SevereMondraker Recalls Mountain Bicycles with ONOFF S9 Carbon Handlebars
CPSC · 2026-09-03
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- High