Synthes Recalls Vertebroplasty Needle Kits Due to Expiration Date Inconsistencies
Synthes USA is recalling 40 Vertebroplasty Needle Kits because of inconsistent expiration dates on the packaging.
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, but the specific hazard is a labeling error (inconsistent expiration dates) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Synthes USA HQ, Inc. is recalling 40 units of the Vertebroplasty Needle Kit 10g Diamond Tip. The recall was initiated after complaints were received regarding inconsistencies in the expiration dates shown on the device packaging.
The affected product is identified by Part No. 03.702.218S and Lot No. AJM838X. These devices are intended to be used to inject PMMA cement into vertebral bodies during a Vertebroplasty procedure. The recall covers nationwide distribution, including Indiana, Montana, Hawaii, and Florida.
Healthcare providers and facilities should stop using the affected devices and contact Synthes USA for further instructions on the recall process.
The recalled product
- Product
- Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 40
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)
- Part No. 03.702.218S
- Lot No. AJM838X
Distribution
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