Synthes Spiked Washers Recalled Due to Mislabeled Size
Synthes USA HQ, Inc. is recalling Spiked Washers 13.5/6.5 because they were mislabeled as 13.5/5.5 during a retrospective assessment.
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: This is a Class II recall involving a labeling error (mislabeling of size) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Synthes USA HQ, Inc. is recalling 3,087 units of Spiked Washers 13.5/6.5. These medical devices are intended for ligament reattachment or fixation, specifically for the readaptation of torn or avulsed ligaments. The recall was initiated after a retrospective assessment discovered that the devices were mislabeled as Spiked Washers 13.5/5.5.
The affected products were distributed nationwide. The recall involves part 219.951 across multiple lot numbers, including 2335941, 2339634, 2397429, 2405812, 2440475, 2442736, 2496414, 5661855, and 5663841.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Patients who have had these devices implanted should consult their healthcare provider regarding the mislabeling.
The recalled product
- Product
- Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 3,087
Distribution
Distributed nationwide across the United States.
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