Integra Leyla Ball Joint Clamp Recalled for Potential Instability
Integra Limited is recalling 65 Leyla Ball Joint Clamps because they may not provide sufficient stability to maintain retraction during neurosurgery.
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 involves a medical device with a functional defect (instability) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integra Limited is recalling 65 units of the Leyla Ball Joint Clamp (Catalog Number R2383) and the Leyla Table Mounting Hardware (Catalog Number R2385). These devices are part of the Leyla Retraction System, a self-retaining retractor used to hold the edges of a wound open during neurosurgery.
The recall was initiated after complaint investigations identified a potential that the Leyla Ball Joint Clamp may not provide the level of stability needed to maintain retraction in all cases. The affected units include all lot numbers and date codes going back to January 2006.
The recalled products were distributed worldwide, including in the United States (specifically Puerto Rico and 23 states) and in Spain, Singapore, South Africa, Canada, Libya, Pakistan, and the Cayman Islands. Healthcare facilities and users should stop using the affected devices and contact Integra Limited for further instructions.
The recalled product
- Product
- Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open…
- Manufacturer
- Integra Limited
- Affected units
- 65
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)
- Catalog Number R2383 and as a component of catalog number R2385
- including all lot numbers date codes going back to January 2006.
Distribution
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