Heraeus Medical Recalls PALACOS MV Pro Bone Cement Due to Leakage Risk
Heraeus Medical is recalling PALACOS MV pro 40 and 80 bone cement due to a potential for monomer liquid leakage. The recall covers all lot numbers distributed worldwide.
What this means for you
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 is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Heraeus Medical GmbH (Dental Division) is recalling PALACOS MV pro 40 and PALACOS MV pro 80, which are radiopaque, poly(methyl methacrylate)-based (PMMA) bone cements. These products are pre-filled into a mixing and application system and are suitable for use with or without vacuum. The recall is being conducted because of a potential for monomer liquid leakage.
The affected products include model/catalog numbers 5150633 and 5150635. The recall covers all batch numbers and all lot numbers. The UDI-DI codes for the affected items are 04260102135338 and 04260102135369.
The products were distributed worldwide, including in the United States and numerous international locations such as Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom. Users should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
- Manufacturer
- Heraeus Medical GmbH (Dental Division)
- Category
- Medical Device — Bone Cement
- Hazard
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)
- Lot Code: UDI-DI: 04260102135338
- 04260102135369. All Batch Numbers. All Lot Numbers.
Distribution
Distributed nationwide across the United States.
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