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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83246

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

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Event summary

Timeline bucket
June 18, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ad-Tech Medical Instrument Corporation

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

LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor bolt body with anchor bolt cap containing a green gasket and silicone cap, 26mm non-anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap - Product Usage: The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.

Z-2204-2019
Recall number
Z-2204-2019
Initiated
June 18, 2019
Classification
Class II
Status
Terminated
Quantity
201 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one international distributor, who may have subsequently sterilized the non-sterile anchor bolts for clinical use. Ad-Tech does not have regulatory clearance to distribute non-sterile anchor bolts and does not have a validated hospital sterilization method for these devices. Further, Ad-Tech labeling does not include instructions for sterilizing anchor bolts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

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Inspect official wording and provenance

Reason for recall

On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one international distributor, who may have subsequently sterilized the non-sterile anchor bolts for clinical use. Ad-Tech does not have regulatory clearance to distribute non-sterile anchor bolts and does not have a validated hospital sterilization method for these devices. Further, Ad-Tech labeling does not include instructions for sterilizing anchor bolts.

Code information

All codes shipped between March 1, 2019 and May 31, 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the state of Georgia and country of Australia.