Z-1126-2020Class II

SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

Name: Z-1126-2020 SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Creator: Implant Direct Sybron Manufacturing LLC
Published: 2019-01-09
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2019-01-09 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing LLC began a recall of SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 on 2019-01-09. FDA classified it as Class II and gives the reason as "Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the...". 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-1126-2020
Classification: Class II
Status: Terminated
Initiated: 2019-01-09
Posted: 2020-02-10
Terminated: 2021-04-27
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 01/09/2019 the firm sent an "Urgent Field Safety Notices to all affected consignees via FedEx Overnight mail. The recall does not include any US consignees. In addition to informing consignees about the recall the notification asked customer to take the following actions: 1. Please review your inventory for the affected product. If so, please quarantine the affected product and return the product to us according to the instructions on the attached form. 2. Please complete and return the Acknowledgement Form within 48 whether you have affected product or not. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification. 4. If you have any of the affected product listed above, please return the product and we will send you a replacement part. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 00800 4030 4030 during the hours of 8:00AM to 5:30PM ET Monday through Thursday and 8:00AM to 5PM ET on Friday. The appropriate Regulatory Agencies have been notified of this action.
Quantity in commerce: 11 units
Distribution: US: None OUS: Iceland, Sweden, Spain,
Product codes and lots: Lot # 109038 No affected devices distributed within the US.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1126-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1126-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-10

Product code NHA

K081396Class IISwissplant Dental Implant SystemImplant Direct, LLC / cleared 2009-01-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)