Z-1823-2017Class II

Tapered SwissPlus Implant System, Model No. SPB10

Name: Z-1823-2017 Tapered SwissPlus Implant System, Model No. SPB10
Creator: Zimmer Dental Inc
Published: 2017-03-20
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2017-03-20 / Terminated / root cause: manufacturing process

FDA source

Zimmer Dental Inc began a recall of Tapered SwissPlus Implant System, Model No. SPB10 on 2017-03-20. FDA classified it as Class II and gives the reason as "It was manufactured with the minor diameter of the internal thread that is below specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1823-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-20
Posted: 2017-04-14
Terminated: 2017-11-01
Recalling firm: ZimVie US Corp LLC
Product: Tapered SwissPlus Implant System, Model No. SPB10
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: It was manufactured with the minor diameter of the internal thread that is below specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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].
Quantity in commerce: 188 units
Distribution: Worldwide: ZA, FR, IT, IR
Product codes and lots: Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1823-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1823-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-14

Product code DZE

K082639Class IIZimmer Dental Tapered Swissplus ImplantsZimmer Dental, Inc. / cleared 2008-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)