Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Test Failures
Zimmer Biomet is recalling sterile knee implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves packaging design verification test failures without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged knee joint femorotibial meta/polymer constrained cemented prosthesis implants. The specific product involved is the Segmental fluted stem, 19x190mm str, sterile, with item number 00585205219 and lot numbers expiring before March 2027.
The recall was initiated due to packaging design verification test failures. The source text does not specify the exact nature of the packaging defect or any resulting clinical harm, but the failure occurred in the sterile packaging configuration.
A total of 9,867 units were distributed worldwide, including the United States and numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, and others. Consumers and healthcare providers should contact Zimmer Biomet for further instructions on how to handle these specific implants.
The recalled product
- Product
- Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
- 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: 00585205219
- Lot Number Expiry Date Before: March 2027
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 · packaging failure
See all →- HighTecFlox hair and beard serum bottles lack child-resistant packaging
CPSC · 2026-04-02
- HighTuymec minoxidil hair growth kits lack child-resistant packaging
CPSC · 2026-04-02
- High
- HighMediHoney wound gel recalled over potential packaging failures
FDA (Devices) · 2026-02-25
- HighMediHoney paste tubes recalled over packaging failures breaching the sterile barrier
FDA (Devices) · 2025-09-10