LSB Style Anchor Bolt recalled over sterility concerns

Recall date

June 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ad-Tech Medical Instrument Corporation recalls LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing…

Recall number

Z-2204-2019

FDA classification

Class II

Brand / firm

Ad-Tech Medical Instrument Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.