Zimmer Biomet Recalls Orthosize Templating Software Due to Incorrect Files
Zimmer Biomet is recalling Orthosize Templating Version 1.2.6 digital templates because they were created with incorrect files, affecting preoperative planning for orthopedic surgery.
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 the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. These digital templates are used for preoperative planning of orthopedic surgery. The recall was initiated because the digital templates were created with the incorrect files.
The recall involves 3,232 units. The products were distributed worldwide, including the United States (nationwide including Puerto Rico), Canada, and numerous other countries such as Argentina, Australia, Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
Consumers and healthcare providers should stop using the affected digital templates and contact Zimmer Biomet, Inc. for further instructions on how to proceed.
The recalled product
- Product
- Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
- Manufacturer
- Zimmer Biomet, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 3,232
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 (1)
- Orthosize Templating Version 1.2.6
Distribution
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