Z-1157-2020Class II

Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD...

Name: Z-1157-2020 Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD...
Creator: Implant Direct Sybron Manufacturing LLC
Published: 2019-10-11
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2019-10-11 / Terminated / root cause: packaging

FDA source

Implant Direct Sybron Manufacturing LLC began a recall of Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R on 2019-10-11. FDA classified it as Class II and gives the reason as "Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1157-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-11
Posted: 2020-02-05
Terminated: 2024-04-12
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: On October 11, 2019 the firm sent an "URGENT: MEDICAL DEVICE RECALL" letter via FedEx overnight priority mail. The letter advised the consignees of the recall. In addition, the letter states: We request that you take the following actions immediately:. 1. Please review your inventory for the affected product. If located, 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 fortyeight (48) hours of receipt of this notification, 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 questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. If you or your patients have experienced any issues as a result of the affected products noted in this URGENT: MEDICAL DEVICE RECALL HHE 855710 100419 Rev 01 Status: RELEASED printed 10/10/2019 2:27:23 PM by Jose Trejo www.implantdirect.com | 888-649-6425 communication, you may voluntarily report the incident to the FDA through the MEDWATCH reporting system at the following: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
Quantity in commerce: 78 implants
Distribution: US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO
Product codes and lots: Lot # 68209

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1157-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1157-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-12

Product code DZE

K090234Class IISpectra System Dental Implants 2008Implant Direct, LLC / cleared 2009-05-15

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)