Zimmer Biomet Recalls Patellofemoral Joint Prosthesis Milling Handpieces
Zimmer Biomet is recalling 703 Patellofemoral Joint Prosthesis Milling Handpieces because they may be inoperable due to lack of preventative maintenance, potentially delaying surgery.
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. The hazard is a delay in surgery due to inoperability, which is a moderate risk without reports of direct injury or death.
Plain-English summary
Zimmer Biomet, Inc. is recalling 703 units of the Gender Solutions Patellofemoral Joint Prosthesis Milling Handpiece. The recall affects Item Number 00-5927-040-00 with all serial numbers. The devices were distributed nationwide and in Canada, Hong Kong, Korea, Singapore, China, Venezuela, Australia, Japan, the Netherlands, Germany, India, and Taiwan.
Complaints were reported that the handpiece was inoperable. An investigation determined that these complaints were related to the lack of preventative maintenance, contrary to the recommendations in the instructions for use included with the device. An inoperable device may lead to a delay in surgery.
This is a Class II recall. Healthcare providers should stop using the affected handpieces and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 703
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)
- Item Number 00-5927-040-00 Serial Number All
Distribution
Distributed nationwide across the United States.
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