PALACOS R plus G bone cement recalled because ampoules may not break
Heraeus Medical is recalling PALACOS R+G pro 40 and PALACOS R+G pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
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: Scored 2 because the record's stated consequence is that the product cannot be used, with no patient harm or reported injury.
Plain-English summary
PALACOS R+G pro 40 and PALACOS R+G pro 80, catalog numbers 5081288 and 5081289, is being recalled by Heraeus Medical GmbH. The record describes the product as radiopaque poly(methyl methacrylate)-based bone cement, pre-filled into a mixing device.
The record cites an increase of complaints regarding the breakage of the ampoules within the device systems. An extensive investigation revealed that multiple factors have an impact on ampoule breakage, and an unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no appropriate cement dough is formed.
The record does not state a quantity. Affected product carries UDI-DIs 04260102136182 and 04260102136212. Distribution was international, to countries including Australia, Belgium, Denmark, Finland and Germany. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is that the product cannot be used, and no injuries are reported. Facilities should follow Heraeus Medical's instructions.
The recalled product
- Product
- Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system…
- Manufacturer
- Heraeus Medical GmbH (Dental Division)
- Category
- Medical Device — Bone cement
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: 04260102136182
- 04260102136212
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Heraeus Medical GmbH (Dental Division) 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Heraeus Medical GmbH (Dental Division)
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