Repeater Bone Tamp Recalled for Component Incompatibility in Spinal Fusion
Integrity Implants Inc. is recalling Repeater Bone Tamp devices (Model ASY-00132) due to incompatibility between Revision A bone tamps and Revision C bone funnels used in spinal fusion procedures.
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: Class II medical device recall for surgical implants with no reported illnesses or injuries. Component incompatibility in a risk-of-harm product qualifies as High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integrity Implants Inc. is recalling Repeater Bone Tamp devices, Model ASY-00132. These devices are cylindrical shafts used to push bone graft material through a bone funnel into the FlareHawk interbody fusion device during spinal fusion procedures. The recall is due to incompatibility between the bone tamp (Revision A) and the bone funnels (Revision C).
Nine units with lot number 03200045 were distributed nationwide in California, Florida, Georgia, Kentucky, Louisiana, Massachusetts, Maryland, Tennessee, and Virginia. Healthcare facilities and physicians with affected devices should verify component revisions and contact Integrity Implants Inc. regarding this recall.
The recalled product
- Product
- Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion…
- Manufacturer
- Integrity Implants Inc.
- Affected units
- 9
Distribution
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