Globus Medical Recalls MicroFuse Putty Due to Sterility Assurance Concerns
Globus Medical is recalling MicroFuse Putty because the sterility assurance level cannot be verified. The product is a bone graft extender used in medical procedures.
What this means for you
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. The hazard involves a potential failure of sterility assurance for a medical device, which poses a risk of harm (infection) even though specific injury reports are not detailed in the provided text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported or is theoretical.
Plain-English summary
Globus Medical, Inc. is recalling 193 units of MicroFuse Putty (2.5cc and 10cc) due to concerns regarding the product's sterility. The recall is classified as Class II by the U.S. Food and Drug Administration. The specific issue is that the sterility of the product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
The affected products are identified by specific part numbers and lot numbers: Part number 838.202S (2.5cc) with lot # GBN299BB (expiration October 2013) and lot # GBN355AB (expiration December 2013); and part # 838.210S (10cc) with lot # GBN319AB (expiration November 2013) and lot # GBN320BB (expiration November 2013). The product was distributed nationwide in the USA.
MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure and is used as a bone graft extender with autogenous bone marrow aspirate or autograft. Healthcare providers and patients should contact Globus Medical for further instructions on how to proceed with the recall.
The recalled product
- Product
- Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone
- Manufacturer
- Globus Medical, Inc.
- Affected units
- 193
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 (5)
- Part number 838.202S (2.5cc)
- with lot # GBN299BB and expiration date October 2013
- and lot #GBN355AB
- with expiration date November 2013
- and GBN320BB with expiration date November 2013.
Distribution
Distributed nationwide across the United States.
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