Zimmer Biomet Recalls Sterile Intramedullary Rod Implants Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile intramedullary rod implants and accessories because packaging design verification tests failed.
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 2/5 (Moderate).
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 verification failures without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 9,867 units of sterile segmental malefemale taper, 200mm, rod fixation, intramedullary implants and specific knee, hip, and nail implant accessories. The recall was initiated on February 28, 2017, because the sterile-packaged implants, which were packaged in two different configurations, failed packaging design verification tests.
The affected products are identified by Item Number 00585004620 and have an expiry date before March 2027. The recall covers units distributed worldwide, including the United States and numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, France, India, Japan, and others.
This is a Class II recall. No specific illnesses or injuries are reported in the source text. Healthcare providers and patients should contact Zimmer Biomet for instructions on how to handle the affected devices.
The recalled product
- Product
- Segmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- 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: 00585004620
- 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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