Reported Sep 25, 2019 · Terminated
AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
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?
- AD-TECH Drill Sleeve Guides
- used with Ad-Tech Placement Kits(a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
- Lot codes and dates
- All serial numbers distributed between January 2014 and May 2019
- Amount recalled
- 315 units
Where it was sold
Why it was recalled
The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
This product could cause temporary or reversible health problems — stop using it.
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