Tapered SwissPlus Implant System, Model No. SPB10
FDA Recall Z-1823-2017 · Posted None
Advertisement
Recalling FirmZimmer Dental Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2017-03-20
Date Terminated2017-11-01
Product Quantity188 units
Reason for Recall
It was manufactured with the minor diameter of the internal thread that is below specification.
Firm Action
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 [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide: ZA, FR, IT, IR
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement