Zimmer Biomet Recalls Sterile Porous Femoral Stems Due to Packaging Failures
Zimmer Biomet is recalling sterile porous femoral stems because packaging design verification tests failed. The recall affects units distributed worldwide.
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 is classified as FDA Class II. The hazard involves potential loss of sterility in a medical implant, which poses a risk of harm (infection) even though no specific injuries are reported in the source text, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Zimmer Biomet, Inc. has initiated a field action for sterile-packaged porous femoral stems (18x200mm). The recall was triggered by packaging design verification test failures, which may compromise the sterile integrity of the implants.
The affected product is identified by Item Number 00784301808 and includes lots with expiry dates before July 2026. The recall covers 9,867 units that were distributed nationwide in the United States and in numerous foreign countries, including Argentina, Australia, Belgium, Brazil, Canada, and France.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the replacement or return of these devices. This action is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Por fullct fem st 18x200mm, Sterile,
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 9,867
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)
- Item Number: 00784301808
- Lot Number Expiry Date Before: July 2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 35 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 35 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 · loss of sterility
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighDaig Livewire Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- HighMedihoney Calcium Alginate Dressings Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2026-02-25
- SevereChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging
FDA (Drugs) · 2025-05-28
- HighProxima Drape sterile drapes recalled for potential packaging breach risk
FDA (Devices) · 2025-03-26