Z-3115-2017Class II

Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK)...

Name: Z-3115-2017 Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK)...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2017-06-26
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2017-06-26 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical... on 2017-06-26. FDA classified it as Class II and gives the reason as "The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require". 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-3115-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-26
Posted: 2017-09-11
Terminated: 2021-06-16
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (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 consist 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: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Implant Direct sent an Safety Alert /Advisory Notice letter dated June 26, 2017. Instructions included to review and remove inventory for return to Implant Direct, complete and return the acknowledgement and recall return form, and contact customers and notify the of the recall if product was further distributed. For further questions, please call (888) 649-6425.
Quantity in commerce: 84 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution to the states of : AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of : Canada, Netherlands, Spain, Great Britain, Germany and Switzerland.
Product codes and lots: Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3115-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3115-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-11

Product code LXH

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)