Zimmer Biomet Recalls Sterile Hip Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile hip 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 a packaging verification failure. As no illnesses or injuries are reported and the hazard is related to potential loss of sterility rather than a direct defect in the implant material itself, it fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. has initiated a field action for sterile-packaged hip implants. The specific product involved is the Por fullct fem st 15x200mm, a sterile, semi-constrained hip prosthesis made of metal and polymer with a porous uncemented design. The recall is driven by packaging design verification test failures, which indicate that the packaging may not have been validated to maintain the sterile integrity of the devices.
The field action, initiated on February 28, 2017, covers 9,867 units. These implants were distributed nationwide in the United States and internationally to numerous countries, including Argentina, Australia, Belgium, Brazil, Canada, France, India, Japan, and others. The affected items are identified by Item Number 00784301508 and have expiry dates before March 2027.
Healthcare providers and facilities that have received these implants should stop using them and contact Zimmer Biomet for instructions on return or replacement. Patients who have already received these implants should consult their healthcare provider to discuss any concerns regarding the packaging integrity.
The recalled product
- Product
- Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- 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: 00784301508
- 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.
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