Z-0283-2018Class II

Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery...

Name: Z-0283-2018 Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2017-11-15
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2017-11-15 / Terminated / root cause: labeling and UDI

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to... on 2017-11-15. FDA classified it as Class II and gives the reason as "The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0283-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-15
Posted: 2017-12-21
Terminated: 2018-10-09
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On November 22, 2017, the recalling firm will send consignees customer letters with replacement product, requesting nonconforming product to be returned to Implant Direct with return labels and packaging. The recalling firm will then initiate calls 24 hours after the communication is sent to the clinician; initiate second calls 72 hours after the communication is sent; and initiate third calls 5 working days after the communication is sent. For further questions, please call (818) 444-3300.
Quantity in commerce: 560 units (worldwide)
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Europe, Canada, Australia, Egypt, Jordan, and Lebanon.
Product codes and lots: Lot # 38665, 38825, 42562, 42649, 43810, 45014, 46950, 50165, 45018, 50165, 52360, 52987, 60376, 62435, 64245, 67044, 73431, 73729, 74772, 70293

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0283-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0283-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)