FDA Medical Device Recalls (openFDA)
Zimmer Dental Inc: Tapered SwissPlus Implant System, Model No. SPB10
- Recall number
- Z-1823-2017
- Recalling firm
- Zimmer Dental Inc
- Product
- Tapered SwissPlus Implant System, Model No. SPB10
- Status
- Terminated
- Initiated
- 2017-03-20
- Posted
- not on file
- Terminated
- 2017-11-01
- Reason
- It was manufactured with the minor diameter of the internal thread that is below specification.
- 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 corporatequality.postmarket@zimmerbiomet.com.
- Quantity
- 188 units
- Distribution
- Worldwide: ZA, FR, IT, IR
- Lot, serial or model codes
- Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731
- 510(k) numbers
- ["K082639"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1038806
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28