Synthes Radial Head Prosthesis Recalled for Potential Stem Loosening
Synthes (USA) Products LLC is recalling 50,311 units of the Radial Head Prosthesis System because the radial stem may loosen post-operatively at the stem bone interface.
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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where the hazard is potential post-operative loosening, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Synthes (USA) Products LLC is recalling the Synthes Radial Head Prosthesis System, including surgical instrument motors and accessories. The recall involves 50,311 units that were distributed nationwide in the United States. The product is intended for primary and revision joint replacement of the radial head.
The recall was initiated because there is a possibility that the radial stem may loosen post-operatively at the stem bone interface. This defect is associated with specific part numbers listed in the agency's recall record Z-1124-2017.
The FDA has classified this recall as Class II. Consumers and healthcare providers should contact Synthes (USA) Products LLC for further instructions regarding the affected devices.
The recalled product
- Product
- Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 50,311
Distribution
Distributed nationwide across the United States.
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