Reported Oct 14, 2015 · Terminated
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The…
Integra LifeSciences Corp.
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 LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.
- Lot codes and dates
Cat. No. UCHRAPSerial No.s 900901902904905906
- Amount recalled
- 6 units
Where it was sold
Why it was recalled
Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing.
This product could cause temporary or reversible health problems — stop using it.
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