Reported Aug 14, 2019 · Terminated
LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing…
Ad-Tech Medical Instrument Corporation
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: Ad-Tech Medical Instrument Corporation · 400 W Oakview Pkwy · Oak Creek, WI · 53154-7213
Is this the product you have?
- LSB Style Anchor Bolt
- Labeled with the following parts13mm 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 UsageThe 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
- Lot codes and dates
All codes shipped between March 12019 and May 312019
- Amount recalled
- 201 devices
Where it was sold
- Nationwide
- GA
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.
This product could cause temporary or reversible health problems — stop using it.
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