Reported Sep 4, 2013 · Terminated
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part…
Integra Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra Limited · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- 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 during neurosurgery.
- Lot codes and dates
- Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.
- Amount recalled
- 65
Where it was sold
Why it was recalled
As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.
This product could cause temporary or reversible health problems — stop using it.
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