FDA Device

Tapered SwissPlus Implant System, Model No. SPB10

Hazard

It was manufactured with the minor diameter of the internal thread that is below specification.

What You Should Do

Remedy

A customer letter was sent on 3/20/17 to inform customers that Zimmer Biomet is recalling a single lot of the Tapered SwissPlus 3.7mmD Implant, Lot No. 63498673. The letter informs customers that the recall is due to one (1) lot of part number SPB10 (lot 63498673) that was manufactured with the minor diameter of the internal thread below specification. This condition may cause mating issues with some screws. The condition occurs when the screw used has a minor thread diameter that is closer to the maximum allowed diameter (maximum material condition). However, screws closer to the least material condition will still fit into the implant. Customers with questions or concerns are instructed to call the customer call center at 1-800-854-7091 between 8:00 am and 5:00pm EST, Monday through Friday. Customers are also instructed to email to corporatequality.postmarket@zimmerbiomet.com.

Products

Tapered SwissPlus Implant System, Model No. SPB10
Brand
Zimmer Dental Inc
UPC
Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731

Units Affected

188 units