Reported Jan 29, 2025 · Ongoing
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product…
Integrity Implants Inc.
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: Integrity Implants Inc. · 354 Hiatt Dr · Palm Beach Gardens, FL · 33418-7236
Is this the product you have?
- Brand NameN/A
- Product NameRepeater
- Bone Tamp Model/Catalog NumberASY-00132
- Software VersionN/A
- Product DescriptionThe 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
- ComponentNo
- Lot codes and dates
- Lot CodePart
- NumberASY-00132
- Lot Number03200045
- UDI Number(01)00810004721906(10)03200045
- Amount recalled
- 9
Where it was sold
Why it was recalled
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
This product could cause temporary or reversible health problems — stop using it.
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