Z-2535-2016Class II

Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512

Name: Z-2535-2016 Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512
Creator: Straumann Manufacturing, Inc.
Published: 2016-07-14
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2016-07-14 / Terminated

FDA source

Straumann Manufacturing, Inc. began a recall of Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512 on 2016-07-14. FDA classified it as Class II and gives the reason as "Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2535-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-14
Posted: 2016-08-12
Terminated: 2020-11-20
Recalling firm: Straumann USA, LLC
Product: Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
FDA root cause: Under Investigation by firm
Action: Straumann notified customers via telephone on Thursday, July 14, 2016. Customers with an e-mail address on file were also e-mailed on Friday, July 15, 2016.Straumann notified customers were sent a hard copy letter via UPS on Saturday, July 16, 2016 for delivery on Monday, July 18, 2016. The customers have been notified not to use these implants and to return unused implants to Straumann. The customers that have used the implants have been asked to provide the restorative situation for the implants. Depending on the restorative situation, additional instructions may be necessary to restore the implants.
Quantity in commerce: 33 pieces
Distribution: Nationwide Distribution.
Product codes and lots: Lot Number: LT123

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2535-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2534-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-12
Z-2535-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-12

Product code DZE

K150938Class IIStraumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC / cleared 2015-07-24

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)