Exact FDA event identifier

Event 96099

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: December 20, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Integrity Implants Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1008-2025

Recall number: Z-1008-2025
Initiated: December 20, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Integrity Implants Inc.
Quantity: 9

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).

Code information

Lot Code: Part Number: ASY-00132 Lot Number: 03200045 UDI Number: (01)00810004721906(10)03200045

Distribution pattern

U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.