Biomet Cement Plug Inserter Recalled for Sterilization Validation Issues
Zimmer Biomet is recalling 89 units of the Small Diameter Cement Plug Inserter due to a lack of adequate sterilization validation.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a sterilization validation defect, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 89 units of the Biomet Small Diameter Cement Plug Inserter-Sterile, Item Number 414989. This single-use accessory instrumentation is intended for use during surgical procedures utilizing Small Diameter Cement Plug implant devices. The recall is being conducted because of a lack of adequate sterilization validation.
The affected units were distributed nationwide. The recall covers all lots of the product. No specific dates or additional distribution details are provided in the source text.
Consumers and healthcare providers should stop using the affected devices and contact Zimmer Biomet for further instructions regarding the recall.
The recalled product
- Product
- Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 89
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)
- All lots
Distribution
Distributed nationwide across the United States.
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