AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

Recall Insight

This FDA Devices action (record #Z-0561-2013) was formally reported on December 26, 2012, with the manufacturer initiating the action on November 19, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. BioHorizons Implant Systems Inc is listed as the recalling firm, operating out of Birmingham, AL. Federal records indicate 174 units units are affected.

The documented reason for this recall is: The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Ecuador, Egypt, Fiji, France, Germany, Greece, Hong Kong, India, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.