Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Descr
Summary
The FDA issued a Class II for Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-001 by Integrity Implants Inc.. Reason: Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C)..
Details
Source
Device Recall
External ID
Z-1008-2025
Action Date
2025-01-29
Status
Ongoing
Category
device
Product Description
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 device in spinal fusion procedures. Component: No
Lot/Code Info: Lot Code: Part Number: ASY-00132 Lot Number: 03200045 UDI Number: (01)00810004721906(10)03200045
Quantity Affected: 9
Reason for Recall
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Distribution
U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-20
Company
Palm Beach Gardens, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integrity Implants Inc. has 9 FDA actions in our database, including 5 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integrity Implants Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integrity Implants Inc. have FDA actions?
Integrity Implants Inc. has 9 FDA actions in our database, including 5 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1008-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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