Zimmer Biomet Recalls Sterile Intramedullary Rods Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile intramedullary rods and accessories due to packaging design verification test failures.
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 a packaging defect (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 implants. The specific products involved are XL POR ST 25.5x220mm, bowed, sterile rods for fixation, intramedullary, and accessories, including specific knee, hip, and nail implants.
The recall was initiated because the sterile-packaged implants, which were packaged in two different package configurations, failed packaging design verification tests. The agency classified this recall as Class II.
A total of 9,867 units were distributed worldwide, including in the United States and numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, India, Italy, Japan, and others. The affected item number is 00992125533, with lot numbers having expiry dates before March 2027. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- 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: 00992125533
- 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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